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 Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia (NCT01243151), a randomized phase 1 study. The primary outcome is Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01243151 |
| Phase | Phase 1 |
| Condition | Hypercholesterolemia, Dyslipidemia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 68 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Healthy adult volunteers with hypercholesterolemia were eligible for the study. The registry record describes the safety analysis set as participants who received at least one dose of study drug. Further eligibility details, including specific cholesterol thresholds and other inclusion or exclusion criteria, are not reported in the registry record.
Intervention
Participants received repeated intravenous doses of the investigational drug PF-04950615 (RN316). The adverse-event results identify active-dose groups of 0.25 mg/kg, 0.50 mg/kg, 1.00 mg/kg, and 1.50 mg/kg. The registry record does not report the dosing schedule or the duration of dosing.
Comparator
The control group received placebo. The study is described as randomized, double-masked, and parallel-group. How randomization was generated, how allocation was concealed, and which people were masked are not reported in the registry record.
Primary question
The primary objective was to assess the safety and tolerability of repeated doses. The primary outcome was the number of participants with dose-limiting and intolerable treatment-related adverse events from baseline through follow-up, ending on Day 78. The registry record does not report a single overall primary-outcome comparison across the groups, so the adverse-event counts available should not be treated as a complete numerical answer to that primary question.
The broader study also assessed pharmacokinetics and pharmacodynamics. Listed secondary outcomes include drug exposure and concentration measures, as well as change from baseline in LDL-C at Day 8, 15, 22, 29 and 78. These outcomes describe different aspects of the response to study drug; they do not replace the stated primary safety objective. The record does not provide enough detail to reconstruct the full protocol or determine the planned comparisons among all dose groups.
3. Trial Design
This was a Phase 1, placebo-controlled, randomized, double-masked, parallel-group study of repeated intravenous doses of PF-04950615 (RN316). The registry record reports enrollment of 68 participants. The study began in February 2011, reached primary completion in October 2011, and is listed as completed. The sponsor was Pfizer.
The study population is described as healthy adult subjects with hypercholesterolemia, and the listed conditions include hypercholesterolemia and dyslipidemia. The registry record's safety population included participants who received at least one dose of study drug. It does not report the detailed eligibility criteria or the number assigned to each group beyond the safety counts associated with the adverse-event results.
The adverse-event results distinguish placebo from PF-04950615 dose groups of 0.25 mg/kg, 0.50 mg/kg, 1.00 mg/kg, and 1.50 mg/kg. Although the design is described as randomized and parallel, the dose-group descriptions for arms A through E are blank. The randomization method, allocation concealment, and masking procedures are not reported in the registry record. Nor does it state whether the groups differed only by assigned dose and placebo.
Repeated intravenous dosing is specified, but the interval between doses, number of administrations, infusion details, and treatment duration are not reported in the registry record. The primary outcome covered baseline through the follow-up period ending on Day 78. The listed LDL-C assessments include several specified days, while the pharmacokinetic outcomes include measures such as maximum observed concentration, time to maximum concentration, and apparent clearance. These listings establish the kinds of outcomes assessed, but not the full visit schedule or analysis plan.
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.
Overall Study
| Stage | Placebo | PF-04950615 0.25 mg/kg | PF-04950615 0.50 mg/kg | PF-04950615 1.0 mg/kg | PF-04950615 1.5 mg/kg |
|---|---|---|---|---|---|
| STARTED | 12 | 14 | 14 | 14 | 14 |
| Treated | 12 | 14 | 14 | 13 | 14 |
| COMPLETED | 12 | 13 | 13 | 12 | 14 |
| NOT COMPLETED | 0 | 1 | 1 | 2 | 0 |
Reasons for not completing this period:
| Reason | Placebo | PF-04950615 0.25 mg/kg | PF-04950615 0.50 mg/kg | PF-04950615 1.0 mg/kg | PF-04950615 1.5 mg/kg |
|---|---|---|---|---|---|
| Adverse Event | 0 | 1 | 0 | 0 | 0 |
| Protocol Violation | 0 | 0 | 1 | 0 | 0 |
| Other | 0 | 0 | 0 | 1 | 0 |
| Randomized but not treated | 0 | 0 | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety analysis set included all participants who received at least 1 dose of study drug.
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.
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Characteristic | Unit | Placebo | PF-04950615 0.25 mg/kg | PF-04950615 0.50 mg/kg | PF-04950615 1.0 mg/kg | PF-04950615 1.50 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 12 | 14 | 14 | 13 | 14 | 67 | |
| Age, Continuous | years | 55.3 (SD 13.7) | 52.0 (SD 7.8) | 51.5 (SD 13.0) | 52.5 (SD 14.3) | 55.1 (SD 8.8) | 53.2 (SD 11.5) |
| Sex: Female, Male: Female | Participants | 6 | 6 | 4 | 5 | 6 | 27 |
| Sex: Female, Male: Male | Participants | 6 | 8 | 10 | 8 | 8 | 40 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs), measured over Baseline up to Follow-up period (Day 78).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with dose-limiting and intolerable treatment-related adverse events. It is a safety and tolerability measure: it counts participants who experienced an event meeting the registry's definition during baseline through follow-up, which ends on Day 78. The registry defines an adverse event as an untoward medical occurrence attributed to study drug in a participant who received study drug. It describes the dose-limiting and intolerable treatment-related events as those resulting from drug overdose, withdrawal, abuse, misuse, interactions, dependency, extravasation, or exposure in utero or during breast feeding.
Counting participants with an event is a binary-outcome approach at the participant level: each person either meets the endpoint definition or does not. This can make a safety outcome easy to interpret in principle, but the interpretation depends on a clear definition, consistent event ascertainment, and complete follow-up. It is also distinct from counting every event, because one participant may experience more than one event while still being counted once for a participant-based endpoint.
The registry record does not report the primary endpoint's group-specific participant counts or a single comparison among groups. It therefore does not support a numerical estimate of the primary endpoint effect from the record's listed adverse-event counts alone. Those counts separate serious from other adverse events, and should not be assumed to represent the specifically defined dose-limiting and intolerable treatment-related endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison of placebo with repeated intravenous PF-04950615 at several stated dose levels, with safety and tolerability as the primary objective. Its adverse-event results report participants at risk and participants affected by serious and other adverse events within each group. For serious events, the reported counts are 0 of 12 for placebo, 1 of 14 for PF-04950615 0.25 mg/kg, 0 of 14 for 0.50 mg/kg, 0 of 13 for 1.00 mg/kg, and 0 of 14 for 1.50 mg/kg. These are descriptive counts; the registry record does not report a statistical comparison of serious-event rates.
For other adverse events, the record reports 9 of 12 participants in the placebo group, 8 of 14 in the 0.25 mg/kg group, 5 of 14 in the 0.50 mg/kg group, 7 of 13 in the 1.00 mg/kg group, and 9 of 14 in the 1.50 mg/kg group. These counts summarize participants affected, not the number of separate events. The registry record does not specify in the available results whether these categories overlap, or provide event-level descriptions for each group. The counts should therefore be read as recorded categories, not combined or treated as an exhaustive accounting of all safety outcomes.
The primary outcome is more narrowly defined than these broad serious and other event categories: it concerns dose-limiting and intolerable treatment-related events. Its group-specific results and an overall comparison are not reported in the registry record. In particular, the serious-event counts cannot be substituted for the primary endpoint, and the registry's definition of an adverse event does not mean every serious event was necessarily judged treatment-related.
The record identifies pulmonary embolism as a top serious-event term, with 7.1% reported. It does not provide enough detail to interpret that term as a treatment-caused event or to identify its clinical course. A percentage attached to an event term is a description from the registry, not by itself an estimate of comparative risk or evidence of a causal relationship.
The listed pharmacokinetic outcomes include AUCtau, Tmax, Cmax, plasma decay half-life, apparent clearance, volume of distribution at steady state, and accumulation ratio. LDL-C change from baseline is also listed at Day 8, 15, 22, 29 and 78. Although these outcomes indicate that drug exposure and lipid measurements were assessed, their numerical results and analyses are not reported in the registry record. The available information therefore supports a description of the design and selected adverse-event counts, but not conclusions about comparative efficacy, exposure-response patterns, or the primary safety outcome.
There are no confidence intervals, p-values, or adjusted effect estimates reported in the registry record for the counts discussed. Without those estimates and a stated comparison, the precision and compatibility of the observed group results with a range of possible effects cannot be assessed from the record. Descriptive differences between group counts should not be converted into claims about treatment effect.
9. Statistical Methods Explained
What does a participant count measure?
The primary outcome is expressed as the number of participants meeting a specified event definition. For a binary outcome, the participant is classified according to whether the event occurred during the stated observation period. This is different from a count of all event episodes. If one participant has multiple events, a participant-level endpoint ordinarily records that person as affected rather than counting each episode separately; the precise implementation for this study is not reported in the registry record.
Participant counts are most informative when read alongside the number of participants at risk in the same group, a consistent endpoint definition, and a clear observation period. The registry provides group-specific denominators for its serious and other adverse-event summaries. It does not give corresponding group-specific results for the primary endpoint of dose-limiting and intolerable treatment-related adverse events. The broad adverse-event categories should not be assumed to be equivalent to that primary definition.
How should groups be compared?
In a randomized parallel-group trial, a comparison of groups can help estimate how outcomes differed under the assigned study conditions. Random allocation can reduce systematic differences at the start of a study in expectation, but it does not ensure that groups are identical, especially in a Phase 1 study with limited enrollment. The registry identifies randomization but does not report how the sequence was generated, how allocation was concealed, or whether any adjusted analysis was used.
For binary outcomes, common summaries include the proportion of participants with an event in each group and a contrast between groups. Such summaries need uncertainty estimates to show how precisely the observed data constrain the underlying effect. A confidence interval is a range of values compatible with the data under the statistical model and its assumptions; it conveys uncertainty rather than certainty about an individual participant. No confidence intervals or comparative effect estimates for the primary endpoint are reported in the registry record.
Small event counts can make estimates imprecise, and a group with no observed event does not establish that the underlying event probability is zero. This is a general statistical point, not a finding that can quantify the risk in these groups. The registry's adverse-event counts are descriptive and no formal statistical test for these comparisons is reported.
What do the pharmacokinetic outcomes represent?
The listed pharmacokinetic outcomes characterize drug concentration over time in different ways. AUCtau represents exposure over a dosing interval; Cmax is the maximum observed plasma concentration; and Tmax is the time at which that maximum is observed. The plasma decay half-life describes decline in concentration, while apparent clearance and volume of distribution at steady state are measures used to characterize disposition. The accumulation ratio compares exposure after repeated dosing with a reference exposure. These are general descriptions of the measures named in the registry; the numerical results, calculation details, and model choices are not reported in the registry record.
Repeated dosing can make it important to distinguish a single-dose concentration profile from concentrations after repeated administration. The listed accumulation ratio and steady-state volume indicate that repeated-dose pharmacokinetic properties were considered, but the record does not describe how steady state was defined or whether all participants completed the planned dosing schedule. The actual sampling times and assay methods are not reported in the registry record.
What can planning illustrations tell a reader?
A sample-size calculation is a planning exercise that relates a chosen effect size and statistical assumptions to a target level of precision or probability of detecting that effect. The registry's planning description specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. Any resulting sample-size figures are planning illustrations, not observed power and not results from this trial's randomization.
For non-time-to-event outcomes, the stated convention is participants per arm; time-to-event calculations use a total event count. These distinctions matter because a planned number of participants and an observed number of events answer different questions. The registry record does not report the trial's own sample-size justification, a target effect used in the original design, or an interim-analysis plan. No sample-size estimates are stated in the available trial details, so no numerical planning conclusion can be drawn.
Why can over-dispersion matter?
For count outcomes, a simple statistical model may assume that variability follows a specified relationship to the average count. Over-dispersion occurs when observed variability is greater than that model expects. If it is ignored, standard errors can be too small and confidence intervals or tests can appear more certain than warranted. This is a general consideration for count data, not a reported feature of this trial. The primary endpoint is described as a participant count for a binary event, and the registry does not report a count model, dispersion estimate, or model diagnostics.
Overall, the registry describes outcomes and study structure but does not report enough methodological detail to reproduce the analysis. The statistical analysis plan, methods for missing observations, handling of protocol deviations, and specific inferential procedures are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The record lists 48 outcome measures and 260 analyses. A large collection of outcomes or analyses can raise multiplicity concerns: when many hypotheses are tested, the chance of at least one apparently unusual result can increase if no adjustment or interpretation strategy is used. Whether such concerns applied to specific reported results depends on which analyses were confirmatory, which were exploratory, and whether any adjustment was planned. Those distinctions and any multiplicity-control procedure are not reported in the registry record.
The primary objective is safety and tolerability, while the listed secondary outcomes span pharmacokinetic measures and LDL-C changes at Day 8, 15, 22, 29 and 78. The registry record does not state a hierarchy among these outcomes, identify a single family of tests, or describe how repeated assessments were handled statistically. It is therefore not possible to infer which results, if any, were intended as confirmatory or how multiple comparisons should be interpreted.
The safety analysis population is defined as participants who received at least one dose of study drug. This is a treated-participant definition, rather than a full intention-to-treat definition. The number randomized, the number excluded from the safety population, and the number with missing outcome data are not reported in the registry record. Missing-data assumptions, imputation methods, and sensitivity analyses are also not reported.
These omissions limit assessment of whether every randomized participant was included in each relevant analysis and how incomplete follow-up affected results. The stated primary observation period extends through follow-up ending on Day 78, but the completeness of follow-up and the handling of participants who did not complete it are not reported in the registry record.
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 | 0 | 12 | 0.0% |
| PF-04950615 0.25 mg/kg | 1 | 14 | 7.1% |
| PF-04950615 0.50 mg/kg | 0 | 14 | 0.0% |
| PF-04950615 1.00 mg/kg | 0 | 13 | 0.0% |
| PF-04950615 1.50 mg/kg | 0 | 14 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo | 9 of 12 |
| PF-04950615 0.25 mg/kg | 8 of 14 |
| PF-04950615 0.50 mg/kg | 5 of 14 |
| PF-04950615 1.00 mg/kg | 7 of 13 |
| PF-04950615 1.50 mg/kg | 9 of 14 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | PF-04950615 0.25 mg/kg | PF-04950615 0.50 mg/kg | PF-04950615 1.00 mg/kg | PF-04950615 1.50 mg/kg |
|---|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 0 of 12 | 1 of 14 | 0 of 14 | 0 of 13 | 0 of 14 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | PF-04950615 0.25 mg/kg | PF-04950615 0.50 mg/kg | PF-04950615 1.00 mg/kg | PF-04950615 1.50 mg/kg |
|---|---|---|---|---|---|---|
| Headache | Nervous system disorders | 2 of 12 | 1 of 14 | 4 of 14 | 1 of 13 | 5 of 14 |
| Ecchymosis | Skin and subcutaneous tissue disorders | 0 of 12 | 2 of 14 | 1 of 14 | 1 of 13 | 3 of 14 |
| Diarrhoea | Gastrointestinal disorders | 2 of 12 | 0 of 14 | 1 of 14 | 0 of 13 | 1 of 14 |
| Upper respiratory tract infection | Infections and infestations | 2 of 12 | 0 of 14 | 0 of 14 | 0 of 13 | 2 of 14 |
| Blood creatine phosphokinase increased | Investigations | 0 of 12 | 1 of 14 | 1 of 14 | 2 of 13 | 0 of 14 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 2 of 12 | 0 of 14 | 1 of 14 | 0 of 13 | 1 of 14 |
| Dermatitis contact | Skin and subcutaneous tissue disorders | 1 of 12 | 0 of 14 | 1 of 14 | 1 of 13 | 1 of 14 |
| Fatigue | General disorders | 2 of 12 | 1 of 14 | 0 of 14 | 0 of 13 | 0 of 14 |
| Abdominal pain | Gastrointestinal disorders | 0 of 12 | 1 of 14 | 1 of 14 | 0 of 13 | 0 of 14 |
| Dyspepsia | Gastrointestinal disorders | 1 of 12 | 0 of 14 | 0 of 14 | 1 of 13 | 0 of 14 |
Serious events with the highest arm-level rate: pulmonary embolism (7.1%).
The serious adverse-event summary reports participants at risk and participants affected by serious events for each group. The counts are 0 of 12 for placebo, 1 of 14 for PF-04950615 0.25 mg/kg, 0 of 14 for 0.50 mg/kg, 0 of 13 for 1.00 mg/kg, and 0 of 14 for 1.50 mg/kg. The group denominators are the numbers at risk reported in the safety summary; they should not be treated as the randomized group sizes unless those are separately established.
One participant affected in a group does not indicate how many serious-event episodes occurred, their duration, or their clinical consequences. Likewise, no observed serious events in a group does not establish that such events could not occur. The registry identifies pulmonary embolism as a top serious-event term and reports 7.1%. It does not report enough detail to determine the event's attribution, timing, outcome, or relationship to assigned treatment.
The serious-event summary is not the same as the primary endpoint. The primary endpoint concerns dose-limiting and intolerable treatment-related adverse events, whereas these results are categorized as serious adverse events. The registry record does not establish that the single serious event met the primary endpoint definition. No comparative statistical analysis or uncertainty interval for the serious-event counts is reported.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, double-masked, placebo-controlled Phase 1 study assessed repeated intravenous doses of PF-04950615 in adults with hypercholesterolemia. It reports participant counts for serious and other adverse events and identifies a primary objective centered on safety and tolerability. It also lists pharmacokinetic and LDL-C outcomes. These details describe what the study set out to assess and what selected safety summaries contain.
The available results do not provide the group-specific counts for the primary endpoint of dose-limiting and intolerable treatment-related adverse events, or a single comparison of that endpoint across groups. The serious-event and other-event counts are not substitutes for that endpoint. Nor do the registry entries report numerical findings for pharmacokinetics or LDL-C. It is therefore not possible from the registry record to quantify a comparative primary safety effect or to characterize the listed secondary outcomes.
A randomized design supports comparisons in principle, but a design label alone does not provide the results or their precision. Without comparative estimates, confidence intervals, statistical tests, and more detail on analysis populations and missing data, descriptive counts should not be interpreted as proof of a difference or lack of difference among groups. The small observed event counts also limit what can be inferred about uncommon events; this is a general limitation of sparse safety data, not a calculation of risk for this study.
These results do not establish whether PF-04950615 is effective, ineffective, safe, or unsafe in a broader population. The trial is a Phase 1 study, and the registry record does not report enough outcome or analysis detail to support conclusions about efficacy or generalizability. The appropriate reading is narrower: a record of the study design, stated objectives, and selected adverse-event counts, with substantial gaps in the reported primary outcome and comparative statistical results.
13. Why This Trial Matters Statistically
This study matters statistically because it illustrates the distinction between a stated primary endpoint and the safety summaries that happen to be available. The primary outcome is specifically defined as participants with dose-limiting and intolerable treatment-related adverse events. The registry's reported serious and other adverse-event counts are broader categories, and no group-specific primary-outcome comparison is reported. Keeping those outcomes separate prevents a descriptive safety summary from being mistaken for the trial's primary result.
The trial also shows why denominators matter. A participant count has meaning in relation to the number at risk in the same group and to the period in which events were observed. The registry supplies denominators for the serious and other event summaries, but not the detailed analysis population for the primary endpoint. Sparse event counts can be clinically important to describe while still being statistically imprecise; a zero observed count is not equivalent to certainty that an event cannot occur.
Multiple listed outcomes create a further interpretive issue. Pharmacokinetic measures describe exposure and disposition, while repeated LDL-C assessments describe a biomarker outcome over time. These answer different questions and can involve different statistical approaches. The registry lists many outcomes and analyses but does not report a multiplicity strategy or a hierarchy of tests, so the role of any particular analysis cannot be established from the record.
Finally, statistical interpretation depends on reporting the estimate and its uncertainty, not just the design and endpoint names. The absence of primary comparative results, confidence intervals, and analysis details prevents readers from judging the precision of the primary safety question. The record is consequently useful for understanding the planned scope and selected counts, but incomplete for evaluating comparative effects.
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 limited detail about trial conduct. It does not report the full eligibility criteria, the randomization method, allocation concealment, the masking procedures, or the dosing schedule. Arm descriptions are blank, so details beyond the dose groups named in the adverse-event results are not reported in the registry record.
The primary endpoint's numerical results by group and a direct comparison are not reported in the registry record. The serious and other adverse-event counts cannot fill that gap because their relationship to the more specific primary definition is not established. The registry also does not report event-level details, timing, severity beyond the serious-event category, treatment attribution for the serious-event counts, or outcomes for individual events.
The safety analysis set includes participants who received at least one dose. The number randomized, the number who received no dose, withdrawals, and completeness of follow-up are not reported in the registry record. The record does not describe missing-data handling or explain whether all participants were assessed through the end of the stated follow-up period.
Statistical reporting is also incomplete for interpretation. Comparative estimates, confidence intervals, p-values, covariate adjustments, model specifications, and multiplicity methods are not reported in the registry record. The original sample-size justification and any interim analyses are not reported. Although pharmacokinetic and LDL-C outcomes are listed, their numerical results and analysis details are not reported in the registry record. These gaps limit both reproducibility and assessment of how precisely the study addressed its stated objectives.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia — NCT01243151.
- Registry record last updated 2019-01-22; status last verified 2018-08.
- Results first posted 2019-01-22.
- 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
NCT01243151 is a completed Phase 1, randomized, double-masked, parallel-group, placebo-controlled study sponsored by Pfizer. It enrolled 68 participants and evaluated repeated intravenous PF-04950615 (RN316) in healthy adults with hypercholesterolemia. The study began in February 2011, with primary completion in October 2011.
The primary objective concerned safety and tolerability, with the primary outcome defined as participants with dose-limiting and intolerable treatment-related adverse events through follow-up ending on Day 78. The registry reports group-specific counts for serious and other adverse events, but not a single comparative result for the stated primary endpoint. It also lists pharmacokinetic measures and LDL-C changes at Day 8, 15, 22, 29 and 78.
Details of the statistical analysis, missing-data handling, multiplicity approach, and numerical results for the listed secondary outcomes are not reported in the registry record. The available information supports a description of the design and selected safety counts, but not a full assessment of comparative effects.