This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A First-in-human Study of Single Doses of PF-07328948 Which is Given to Healthy Adult Participants (NCT05654181), a randomized phase 1 study. The primary outcome is Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05654181 |
| Phase | Phase 1 |
| Condition | Healthy |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Double |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Healthy adult participants. The registry record reports enrollment of 20 participants and defines the primary outcome population as participants randomly assigned to study intervention who took at least 1 dose. Participants were analyzed according to the intervention they actually received.
Intervention
Single oral doses of PF-07328948 at escalating dose levels. The cohort descriptions say participants could receive up to 4 dose levels, administered as oral suspensions. The specific dose levels for each cohort were to be determined.
Comparator
Matching placebo, including placebo doses listed as fed. The study is described as placebo-controlled. The cohort descriptions allow up to 2 single doses of matching placebo; they do not establish that every participant received every listed intervention.
Primary question
How many participants reported treatment-emergent adverse events during Day 1-8 per period and the 28-35 day post-final dose follow-up? The study also evaluates safety, tolerability, plasma pharmacokinetics, and pharmacodynamics after single doses. The registry record does not report a single primary comparison between PF-07328948 and placebo.
This is a phase 1, first-in-human study in healthy adults, rather than a study of treatment in people with a specified disease. Its central clinical purpose is to characterize the response to single escalating oral doses, including safety and the way PF-07328948 appears in plasma over time. The listed secondary outcomes include maximum plasma concentration, time to maximum concentration, areas under the plasma concentration-time curve, and terminal half-life.
The design is randomized, double-blind, sponsor-open, placebo-controlled, and crossover. In a crossover study, participants can receive different interventions in different periods, so each person's experience may contribute information about more than one exposure. The cohort descriptions specify potential exposure to multiple dose levels and placebo, but the record does not report the administered sequence for each participant. The clinical question should therefore be read as a safety and pharmacology assessment across exposures, not as a simple comparison of two parallel groups.
3. Trial Design
The registry record identifies NCT05654181 as a phase 1 randomized, double-blind, sponsor-open, placebo-controlled, 4-period crossover, first-in-human study. It enrolled 20 healthy adult participants. The study status is completed; the record lists a start date of 2022-10-17 and a primary completion date of 2023-05-03. These dates describe the registry record and do not establish when results were analyzed or reported.
PF-07328948 and placebo are listed as drug interventions. The three cohort descriptions each state that participants could receive up to 4 dose levels of PF-07328948 as single doses and up to 2 single doses of matching placebo. Doses were administered as oral suspensions, and the dose levels were to be determined. The posted group names include PF-07328948 doses of 10 mg, 30 mg, 100 mg, 300 mg, 750 mg, and 1500 mg, along with placebo and fed groups. The registry record does not describe the sequence in which participants received these interventions or how participants were assigned to cohorts.
The word crossover is important for interpreting the exposure groups. The listed at-risk counts differ across groups, and the record does not show that each group represents a distinct set of participants. Counts from exposure periods should not automatically be treated as counts from independent parallel arms. The record does not report a statistical model for handling repeated exposures or within-participant correlation.
The primary outcome is the number of participants reporting treatment-emergent adverse events, with the stated timeframe of Day 1-8 per period and a 28-35 day post-final dose follow-up. The registry record lists 11 outcome measures and 0 analyses. It does not report a sample-size justification, detailed statistical analysis plan, treatment sequence, or results for the listed pharmacokinetic secondary outcomes.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: A total of 20 participants were enrolled, and received at least one dose of study intervention.
Only the first 6 of 10 groups are shown.
Overall Study
| Stage | PF-07328948 10 mg, PF-07328948 30 mg, PF-07328948 100 mg, Placebo | PF-07328948 10 mg, PF-07328948 30 mg, Placebo, PF-07328948 300 mg | PF-07328948 10 mg, Placebo, PF-07328948 100 mg, PF-07328948 300 mg | Placebo, PF-07328948 30 mg, PF-07328948 100 mg, PF-07328948 300 mg | PF-07328948 750 mg, PF-07328948 F mg, PF-07328948 G mg, Placebo | Placebo, PF-07328948 F mg, PF-07328948 G mg, PF-07328948 H mg |
|---|---|---|---|---|---|---|
| STARTED | 3 | 2 | 2 | 2 | 1 | 1 |
| COMPLETED | 2 | 2 | 2 | 2 | 0 | 0 |
| NOT COMPLETED | 1 | 0 | 0 | 0 | 1 | 1 |
Reasons for not completing this period:
| Reason | PF-07328948 10 mg, PF-07328948 30 mg, PF-07328948 100 mg, Placebo | PF-07328948 10 mg, PF-07328948 30 mg, Placebo, PF-07328948 300 mg | PF-07328948 10 mg, Placebo, PF-07328948 100 mg, PF-07328948 300 mg | Placebo, PF-07328948 30 mg, PF-07328948 100 mg, PF-07328948 300 mg | PF-07328948 750 mg, PF-07328948 F mg, PF-07328948 G mg, Placebo | Placebo, PF-07328948 F mg, PF-07328948 G mg, PF-07328948 H mg |
|---|---|---|---|---|---|---|
| Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 |
| Other | 0 | 0 | 0 | 0 | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Only the first 6 of 11 groups are shown.
| Characteristic | Unit | PF-07328948 10 mg, PF-07328948 30 mg, PF-07328948 100 mg, Placebo | PF-07328948 10 mg, PF-07328948 30 mg, Placebo, PF-07328948 300 mg | PF-07328948 10 mg, Placebo, PF-07328948 100 mg, PF-07328948 300 mg | Placebo, PF-07328948 30 mg, PF-07328948 100 mg, PF-07328948 300 mg | PF-07328948 750 mg, PF-07328948 F mg, PF-07328948 G mg, Placebo | Placebo, PF-07328948 F mg, PF-07328948 G mg, PF-07328948 H mg |
|---|---|---|---|---|---|---|---|
| Participants analysed | 3 | 2 | 2 | 2 | 1 | 1 | |
| Age, Customized: 18-44 years | Participants | 1 | 2 | 2 | 2 | 1 | 1 |
| Age, Customized: 45-60 years | Participants | 2 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 1 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 2 | 2 | 2 | 2 | 1 | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 1 | 1 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 | 1 | 1 | 2 | 1 | 1 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: White | Participants | 0 | 1 | 2 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Black or African American | Participants | 0 | 1 | 0 | 1 | 1 | 1 |
| Race/Ethnicity, Customized: Asian | Participants | 2 | 0 | 0 | 1 | 0 | 0 |
| Race/Ethnicity, Customized: Multiple | Participants | 1 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Not reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs), measured over Day 1-8 per period, along with the 28-35 day post-final dose follow-up.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants reporting treatment-emergent adverse events, or TEAEs. An adverse event is defined in the registry record as an untoward medical occurrence temporally associated with study intervention, whether or not considered related to that intervention. An event is classed as treatment-emergent if it began during the effective duration of treatment. The described algorithm flags events starting on or after the first dosing day and before the end of the study, and does not count events that began before the first dose.
The stated observation window is Day 1-8 per period, along with the 28-35 day post-final dose follow-up. This endpoint is used in early clinical studies to describe the occurrence of unwanted medical events during and after exposure. It is a count of participants, rather than a measure of event severity, duration, or causal certainty. The record separately defines treatment-related adverse events as events attributed to study drug, which is a narrower concept than all events temporally associated with treatment.
Because the outcome is expressed as participants with events, the count alone does not show how many total events occurred or whether a participant experienced more than one event. The posted group data distinguish serious adverse events from other adverse events, but do not provide a complete narrative of each event or a treatment-relatedness judgment for every event. The registry record does not report a single summarized TEAE comparison or an inferential estimate for this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the study as completed and reports safety counts for placebo, fed placebo, and PF-07328948 exposure groups. Among the listed groups, the serious adverse event count is 1 for Placebo, with 13 participants at risk. The count is 0 in each listed PF-07328948 group and in Placebo (Fed). The record reports no deaths in any listed group. The serious-event term listed is Seizure, with 7.7%; the record does not link that term to a specific exposure group in the information available for this analysis.
The counts for other adverse events vary by exposure group. The posted figures include 3 participants affected among 13 at risk for Placebo, 1 among 2 for Placebo (Fed), 3 among 6 for PF-07328948 10 mg, 2 among 5 for 30 mg, 1 among 5 for 100 mg, 5 among 12 for 300 mg, 3 among 7 for 750 mg, 1 among 5 for 750 mg (Fed), and 2 among 6 for 1500 mg. These are descriptive counts, not adjusted comparisons. The at-risk counts differ, and the crossover design means that the groups should not be presumed to be independent sets of participants.
No p-values, confidence intervals, or treatment-effect estimates for the primary outcome are reported in the registry record. It lists 0 analyses and indicates that the primary outcome has several categories or time points and was not reduced to one comparison. Consequently, the posted counts do not establish a formal difference between PF-07328948 and placebo. Nor do they establish that the interventions had equivalent safety profiles: absence of an inferential comparison is not evidence of equivalence.
For a binary event outcome, a confidence interval would describe the range of values compatible with the observed data under a specified statistical method. No such interval is reported for these counts. With small and varying at-risk groups, event counts can be imprecise descriptions of the underlying event frequency. That general limitation is especially relevant when an exposure group has few participants at risk. The record does not provide enough information to estimate a more precise comparative effect.
The study's scope also constrains interpretation. It is a phase 1 first-in-human investigation in healthy adults, with single doses and pharmacology outcomes in addition to safety. The posted results do not establish effects in patients, outcomes under repeated dosing, or effects on a clinical disease. The appropriate reading is descriptive: the registry reports the listed event counts, but does not provide a statistical analysis that supports a comparative conclusion.
9. Statistical Methods Explained
The registry record describes a randomized, double-blind, sponsor-open, placebo-controlled crossover study. Randomization assigns participants by chance to study allocations, while blinding is intended to limit knowledge of intervention assignment. The record does not describe who was blinded, the randomization procedure, or the handling of treatment sequence. Those details are not reported in the registry record.
What does a crossover design imply?
General statistical explanation: in a crossover design, a participant may receive more than one intervention across different periods. This can allow comparisons that account for stable differences between participants, because a participant's responses under different exposures can be considered together. However, the periods and exposures are not automatically independent observations. Valid analysis may need to address within-participant correlation, period effects, sequence effects, and possible carryover from an earlier intervention. The registry record does not report how these features were addressed statistically, so no particular model or adjustment should be assumed.
The cohort descriptions state that participants could receive up to 4 dose levels of PF-07328948 and up to 2 single placebo doses. The listed at-risk counts vary across exposure groups. This variation reinforces the need to distinguish exposure-level counts from a conventional comparison of separate, parallel groups. The registry record does not give individual participant exposure histories or the order of treatment periods.
What kind of endpoint is reported?
The primary endpoint is a binary participant-level event measure: whether a participant reported a TEAE during the specified follow-up. The posted group summaries give numbers of participants at risk and numbers affected for serious and other adverse events. A count is straightforward to describe, but it does not by itself account for unequal group sizes, repeated exposure, event timing, or differences in participant follow-up. A rate or model-based comparison would require a specified denominator and analysis method; the record does not report such a comparative analysis.
General statistical explanation: a confidence interval communicates uncertainty around an estimate and depends on both the observed data and the method used to calculate it. A p-value, when reported, assesses compatibility of data with a specified null hypothesis under model assumptions; it does not measure clinical importance or prove that a treatment effect is absent. Neither a confidence interval nor a p-value for a primary comparison is reported in the registry record. Without these, the counts remain descriptive rather than evidence of a statistically established contrast.
Why does event rarity matter?
General statistical explanation: when events are uncommon and group sizes are small, estimates are often unstable. A change in a small number of observed participants can materially change a proportion or comparative estimate. Over-dispersion is a general concern when variability in event counts exceeds what a chosen model expects; it can make standard errors too small if not addressed. The registry record does not report an over-dispersion assessment or a model for these safety data. No claim about the presence or absence of over-dispersion can therefore be made.
The reported at-risk counts are not identical across exposure groups. Directly comparing raw counts without accounting for their denominators would not be a fair comparison. Even a comparison based on percentages would need to consider the crossover structure and repeated exposures; the posted record does not provide such an analysis. The single listed serious-event term, Seizure, is accompanied by 7.7%, but the record does not specify its exposure-group attribution in the registry record reported for interpretation. It should not be assigned to a treatment group without that information.
What do the planning calculations mean?
General statistical explanation: sample-size calculations describe how many participants might be needed under stated assumptions to detect a specified effect with a chosen error rate and power. Such calculations are planning illustrations, not observed properties of the completed trial. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For non-time-to-event outcomes, the planning quantity is participants per arm. The registry record does not report a trial-specific sample-size justification, so planning illustrations should not be read as evidence about the original design rationale or as observed power.
The record lists 11 outcome measures but 0 analyses. The absence of listed analyses means that no reported inferential results can be attributed to the registry entry. The statistical analysis plan, including any planned models or adjustments, is not reported in the registry record. A detailed model should not be reconstructed from the outcome labels alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 11 outcome measures, including a primary safety endpoint and pharmacokinetic outcomes such as maximum concentration, time to maximum concentration, area under the plasma concentration-time curve, and terminal half-life. It lists 0 analyses. The record does not report a multiplicity strategy, such as a hierarchy of hypotheses, adjustment of significance levels, or a distinction between confirmatory and exploratory analyses. Without such information, the outcomes cannot be interpreted as a coordinated family of hypothesis tests.
The primary endpoint is described over Day 1-8 per period and the 28-35 day post-final dose follow-up. The registry record indicates that the primary outcome has several categories or time points and was not reduced to one comparison. No single treatment contrast, test, or estimate is reported. This makes it inappropriate to treat the posted adverse-event counts as if they were the result of one prespecified statistical test.
The outcome population is defined as participants randomly assigned to study intervention who took at least 1 dose, analyzed according to the intervention they actually received. This is the population definition stated for the primary outcome. The record does not report how missing outcome observations were handled, whether participants with incomplete follow-up were excluded from particular summaries, or whether any sensitivity analyses were conducted. It also does not describe an intention-to-treat analysis or a per-protocol analysis.
General statistical explanation: missing-data handling matters because a participant without complete follow-up may have an unobserved event status. Excluding such participants, assuming no event, or using a model to account for missingness can lead to different interpretations, depending on the assumptions. These procedures are not described in the registry record. The record also does not report a multiplicity adjustment or missing-data sensitivity analysis, so neither should be presumed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Placebo | 1 | 13 | 7.7% |
| Placebo (Fed) | 0 | 2 | 0.0% |
| PF-07328948 10 mg | 0 | 6 | 0.0% |
| PF-07328948 30 mg | 0 | 5 | 0.0% |
| PF-07328948 100 mg | 0 | 5 | 0.0% |
| PF-07328948 300 mg | 0 | 12 | 0.0% |
| PF-07328948 750 mg | 0 | 7 | 0.0% |
| PF-07328948 750 mg (Fed) | 0 | 5 | 0.0% |
| PF-07328948 1500 mg | 0 | 6 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 13 |
| Placebo (Fed) | 0 of 2 |
| PF-07328948 10 mg | 0 of 6 |
| PF-07328948 30 mg | 0 of 5 |
| PF-07328948 100 mg | 0 of 5 |
| PF-07328948 300 mg | 0 of 12 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo | 3 of 13 |
| Placebo (Fed) | 1 of 2 |
| PF-07328948 10 mg | 3 of 6 |
| PF-07328948 30 mg | 2 of 5 |
| PF-07328948 100 mg | 1 of 5 |
| PF-07328948 300 mg | 5 of 12 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | Placebo (Fed) | PF-07328948 10 mg | PF-07328948 30 mg | PF-07328948 100 mg | PF-07328948 300 mg |
|---|---|---|---|---|---|---|---|
| Seizure | Nervous system disorders | 1 of 13 | 0 of 2 | 0 of 6 | 0 of 5 | 0 of 5 | 0 of 12 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Placebo (Fed) | PF-07328948 10 mg | PF-07328948 30 mg | PF-07328948 100 mg | PF-07328948 300 mg |
|---|---|---|---|---|---|---|---|
| Headache | Nervous system disorders | 1 of 13 | 0 of 2 | 1 of 6 | 0 of 5 | 0 of 5 | 2 of 12 |
| Application site dermatitis | General disorders | 2 of 13 | 0 of 2 | 0 of 6 | 0 of 5 | 0 of 5 | 0 of 12 |
| Fatigue | General disorders | 0 of 13 | 0 of 2 | 0 of 6 | 0 of 5 | 0 of 5 | 1 of 12 |
| Vessel puncture site bruise | General disorders | 0 of 13 | 0 of 2 | 1 of 6 | 0 of 5 | 0 of 5 | 0 of 12 |
| Vessel puncture site pain | General disorders | 0 of 13 | 0 of 2 | 0 of 6 | 0 of 5 | 0 of 5 | 1 of 12 |
| Acute sinusitis | Infections and infestations | 1 of 13 | 0 of 2 | 0 of 6 | 0 of 5 | 0 of 5 | 0 of 12 |
| COVID-19 | Infections and infestations | 0 of 13 | 0 of 2 | 1 of 6 | 0 of 5 | 0 of 5 | 0 of 12 |
| Pharyngitis streptococcal | Infections and infestations | 0 of 13 | 0 of 2 | 0 of 6 | 0 of 5 | 1 of 5 | 0 of 12 |
| Upper respiratory tract infection | Infections and infestations | 0 of 13 | 0 of 2 | 0 of 6 | 1 of 5 | 0 of 5 | 0 of 12 |
| Neurological symptom | Nervous system disorders | 1 of 13 | 0 of 2 | 0 of 6 | 0 of 5 | 0 of 5 | 0 of 12 |
Serious events with the highest arm-level rate: seizure (7.7%).
The safety summaries distinguish serious adverse events from other adverse events and give, for each listed exposure group, the number at risk and the number affected. One serious adverse event is reported for Placebo, with 13 participants at risk. The serious-event count is 0 for Placebo (Fed) and for each listed PF-07328948 exposure group. No deaths are reported in any listed group. The serious adverse event term listed is Seizure, with 7.7%; the record does not identify the associated exposure group in the information.
Other adverse events are reported in the listed groups, with the affected counts and at-risk counts varying across exposures. These figures are counts of participants, not counts of all event episodes, and they do not identify whether an event was judged related to study intervention. The record's definition of treatment-related AE requires attribution to study drug, while an adverse event can be recorded whether or not it is considered related.
Because the trial is crossover and the group denominators vary, exposure-group counts should not be read as results from independent parallel arms. The registry record does not report a formal comparison or uncertainty interval for the safety counts. The figures describe what was recorded; they do not by themselves establish a causal relationship, a comparative risk, or the absence of risk.
12. What the Result Does, and Does Not, Mean
The posted record documents a first-in-human phase 1 study of single escalating oral doses of PF-07328948 in healthy adults. It reports safety counts across placebo and PF-07328948 exposure groups, including one serious adverse event in the Placebo group, no serious adverse events in the listed PF-07328948 groups, and no deaths. It also reports other adverse events in each of the listed treatment groups. These details describe the registry results; they do not amount to a formal comparative analysis.
The registry record does not report a primary treatment-effect estimate, confidence interval, or p-value. It identifies 0 analyses and notes that the primary outcome has several categories or time points and was not reduced to one comparison. Therefore, the available data cannot establish whether the recorded event counts differ statistically between PF-07328948 and placebo. They also cannot establish equivalence or rule out differences that the study was not able to characterize precisely.
General statistical explanation: an observed count is an estimate based on the participants and follow-up represented in that summary. It is not a guarantee that the same count or frequency would occur in another group or setting. Uncertainty is particularly important for uncommon events, because a small number of observations provides limited information about their frequency. The record does not provide uncertainty intervals for the reported counts.
The results should not be extended beyond the study's population and exposure conditions. This was a study in healthy adults, with single doses and a crossover design. The registry record does not establish outcomes in patients, longer-term use, repeated dosing, or clinical benefit for a disease. Pharmacokinetic outcomes are listed, but their results are not reported in the registry record. The most defensible interpretation is limited to the descriptive information: the event counts and follow-up definitions recorded, without a reported statistical comparison or broader clinical conclusion.
13. Why This Trial Matters Statistically
This trial is statistically notable because its first-in-human, crossover structure combines early safety observation with escalating single-dose exposure and pharmacology objectives. The study was randomized, double-blind, sponsor-open, and placebo-controlled, and the cohort descriptions allow participants to receive multiple dose levels and placebo. That structure makes it important to distinguish the number of participants from the number of treatment exposures. The listed exposure-group denominators vary, and the registry record does not report the treatment sequences or an analysis addressing repeated observations.
The primary endpoint is a count of participants with treatment-emergent adverse events, but the registry record does not reduce the several categories or time points to a single comparison. This illustrates a key interpretive issue in safety reporting: descriptive counts can be informative, while still falling short of a statistical comparison. Without an estimate and its uncertainty, readers cannot assess the precision of a difference between interventions from the registry record alone.
The record lists 11 outcome measures but 0 analyses. It also does not report the trial's sample-size justification, statistical analysis plan, or approach to multiplicity and missing data. Those omissions do not negate the descriptive information, but they limit what can be inferred about the planned and executed statistical analysis.
General statistical explanation: early studies often generate information about tolerability and pharmacology that can inform later research questions, while estimates from small groups may remain uncertain. The sample-size illustrations associated with the posted results are planning scenarios under stated assumptions, not evidence of observed power or a description of the original design rationale. Keeping those roles distinct helps prevent descriptive observations and planning calculations from being mistaken for confirmatory evidence.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record provides aggregate safety counts, but not participant-level data, event narratives, exposure sequences, or the timing of each event by treatment period. It does not report whether the serious adverse event listed as Seizure occurred in a particular exposure group. The listed term and 7.7% should therefore be interpreted without attributing it to PF-07328948 or placebo.
The at-risk counts vary across the listed groups, and the study is a crossover trial. The registry record does not explain why the group denominators differ or show which participants contributed to multiple exposure groups. Raw counts across those groups therefore do not form a straightforward comparison of independent treatment arms. No model accounting for within-participant dependence is reported.
The record does not report a single primary comparison, effect estimate, confidence interval, or p-value. It also does not provide results for the listed pharmacokinetic outcomes, a statistical analysis plan, a sample-size justification, treatment sequence details, or methods for handling missing outcome data and multiplicity. The reason for the absence of those details is not reported in the registry record.
The study enrolled healthy adults and evaluated single doses. The registry information does not establish how the findings would apply to patients, other populations, repeated dosing, or longer-term exposure. The adverse-event counts are descriptive and the record does not provide enough information to assess all aspects of severity, duration, relatedness, or recurrence. These limitations constrain interpretation of the posted safety information and do not support conclusions beyond the outcomes and population described.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A First-in-human Study of Single Doses of PF-07328948 Which is Given to Healthy Adult Participants — NCT05654181.
- Registry record last updated 2024-11-05; status last verified 2024-11.
- Results first posted 2024-11-05.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT05654181 is a completed phase 1, randomized, double-blind, sponsor-open, placebo-controlled, 4-period crossover, first-in-human study of single oral doses of PF-07328948 in healthy adult participants. The registry record reports enrollment of 20 and lists Pfizer as sponsor. Its primary outcome is the number of participants reporting treatment-emergent adverse events during Day 1-8 per period and the 28-35 day post-final dose follow-up.
The posted safety summaries list serious and other adverse events across placebo and PF-07328948 exposure groups, with differing at-risk counts. One serious adverse event is reported in the Placebo group; none are reported in the listed PF-07328948 groups. No deaths are reported. The record lists 11 outcome measures and 0 analyses, and does not report a single primary comparison or inferential estimate. Accordingly, the safety results are descriptive and should be interpreted in light of the crossover design, the small enrolled population, and the unreported analysis details.