A Study to Test the Effects of Kindolor at Different Doses in Healthy Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Test the Effects of Kindolor at Different Doses in Healthy Adults (NCT06243835), a randomized phase 1 study. The primary outcome is Number of Participants With Treatment-Emergent Adverse Events (TEAEs).

2. Clinical Question

3. Trial Design

This was a randomized, double-blind, placebo-controlled, parallel-group Phase 1a study at a single site. Its official title describes a single ascending dose study of the safety, tolerability, and pharmacokinetics of Kindolor Tosylate in healthy adults. The registry record lists enrollment of 16 and status as terminated. The start date was 2024-04-21, and the primary completion date was 2024-11-22. The reason for termination is not reported in the registry record.

The intervention arms were organized as Kindolor cohorts, with a placebo comparator. The record includes dose descriptions for four Kindolor cohorts, but the posted primary results contain outcome values only for Kindolor Cohort 1, Kindolor Cohort 2, and the placebo comparator. The cohort descriptions for Kindolor Cohort 3 and Kindolor Cohort 4 refer to 3 tablets dose 300mg and 6 tablets dose 300mg; the registry wording does not make clear how to interpret those dose descriptions. No outcome counts for these cohorts are reported in the posted primary results.

Randomization and double masking are listed as design features, but allocation procedures, concealment details, and the practical method of maintaining masking are not reported in the registry record. The registry record does not explain how participants were assigned across the cohorts or whether assignment was stratified. It also does not report the planned sample size for each cohort, a sample-size justification, or the protocol’s statistical analysis plan. These omissions limit how fully the registered design can be compared with the posted results.

The study aimed to assess safety and pharmacokinetics after dosing, rather than to estimate a clinical effect in people with chronic pain. Six pharmacokinetic outcomes are listed, including exposure and concentration-time measures. Their numerical results are not reported in the record analyzed.

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

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: The baseline analysis population includes all subjects who were enrolled and received the single protocol-specified dose of the investigational product. Baseline characteristics were recorded prior to this single administration.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Treatment-Emergent Adverse Events (TEAEs), measured over From Day 1 to Day 7.

The primary endpoint is the number of participants with treatment-emergent adverse events (TEAEs), assessed from Day 1 to Day 7. The registry definition counts an adverse event as treatment-emergent if it began or worsened in severity after the first administration of investigational product. The endpoint is therefore a participant count: it records whether participants experienced a qualifying event, rather than how many separate events each participant had or how severe those events were.

General statistical context: in an early-phase safety study, counting participants with events can provide a direct descriptive account of how often an adverse event was observed in each study group. It is useful for presenting safety observations alongside dose escalation and pharmacokinetic measurements. It does not, by itself, establish that a treatment caused an event; events can arise for other reasons, and interpretation also depends on the study design and the completeness of event ascertainment.

The record defines the event window and the treatment-emergent criterion, but does not report a severity threshold for inclusion in the primary endpoint. Serious adverse events are reported separately in the safety information. The posted primary counts are 6 participants in Kindolor Cohort 1, 6 in Kindolor Cohort 2, and 3 in the placebo comparator. The corresponding group sizes reported with these results are 6, 6, and 4. No primary endpoint counts are reported for Kindolor Cohort 3 or Kindolor Cohort 4. The registry record does not report an inferential comparison or confidence intervals for these counts.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is binary at the participant level: a participant either had a treatment-emergent adverse event during the defined assessment period or did not. The registry record presents the number of participants meeting that definition and the group size for each arm with reported results. This format allows a reader to see the observed event counts alongside the participants assessed in each group. The endpoint is not a measure of the total number of events, and it does not encode event severity.

What can a participant count tell a reader?

General statistical context: a count describes what was observed in the participants represented in a group. It is useful for an early safety summary because it is readily interpretable and preserves the distinction between people who experienced an event and the number of event episodes. However, a count alone gives limited information about uncertainty. Statistical precision depends on the amount of information in the data and the number of participants observed. A confidence interval, when reported, expresses a range of values compatible with the observed data under the method’s assumptions. No confidence interval for the primary endpoint is reported in the registry record.

The result values are 6 participants for Kindolor Cohort 1, 6 participants for Kindolor Cohort 2, and 3 participants for the placebo comparator. The group sizes are 6, 6, and 4, respectively. These are the values posted for the primary endpoint; they should not be extended to the Kindolor cohorts without posted results. The registry record reports no primary counts for Kindolor Cohort 3 or Kindolor Cohort 4.

Why is a formal comparison not presented?

The record indicates that values are missing or not estimable for a two-arm comparison of this binary endpoint. Therefore, a recalculated comparison is not available from the posted summary statistics. The absence of a comparison is not evidence that the groups are identical, and it is not evidence of a statistically established difference. It means the record does not support a reported inferential estimate for that contrast. No sponsor analysis or test result is reported for this endpoint, and the record does not flag a discrepancy between a sponsor result and a recalculation.

General statistical context: a comparison of binary outcomes may be expressed as a difference in proportions or another measure of relative association. Such measures depend on the selected statistical method and typically require uncertainty estimates for interpretation. In small groups, estimates can be imprecise, and the choice of method can affect the result. Over-dispersion is more relevant to outcomes that count repeated events, where the observed variation may exceed what a basic count model assumes. The primary endpoint counts participants with an event, not repeat event totals, and the record does not report a model accounting for over-dispersion.

What do the planning assumptions mean?

The registry record describes a sample-size planning illustration based on the observed effect, with 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. This is a planning exercise, not the trial’s original design justification. The registry record does not report the trial’s own sample-size justification or establish that the trial was designed around those assumptions. Any resulting sample-size quantities are planning illustrations, not observed power. Because a two-arm comparison for the binary endpoint is recorded as not estimable, such planning quantities should not be mistaken for evidence that an effect was detected.

General statistical context: power is a design property associated with a specified effect size, variability, analysis method, significance threshold, and sample size. A post hoc calculation using an observed effect does not show the probability that a reported finding is true or that a treatment has a particular effect. Planning for a fraction of an observed effect asks what sample size might be needed under stated assumptions to detect a smaller target effect; it does not establish that the target effect is clinically important. The registry record does not report a protocol-based sample-size calculation, interim analysis plan, or detailed statistical analysis plan.

The primary measure is reported as a count of participants. No inferential test, adjustment method, or confidence interval is stated in the registry record. The absence of those methods means the descriptive group values should not be read as the output of an adjusted model. It also prevents an assessment of model assumptions or the handling of any within-participant correlations that might arise in repeated measurements.

The study also lists six pharmacokinetic outcomes: AUCt, AUC∞, Cmax, Tmax, λz, and t1/2 for Kindolor Tosylate. These are distinct types of pharmacokinetic summaries, but numerical results and analysis methods for them are not reported in the registry record. Without those values and methods, their precision and the relationship between exposure and the safety findings cannot be assessed.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Kindolor Cohort 1", "Kindolor Cohort 2", "Placebo Comparator")
n      <- c(6, 6, 4)
events <- c(6, 6, 3)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Kindolor Cohort 1  6  6  100.0  54.1  100.0  61.0  100.0  59.0  99.6
ARM  Kindolor Cohort 2  6  6  100.0  54.1  100.0  61.0  100.0  59.0  99.6
ARM  Placebo Comparator  4  3  75.0  19.4  99.4  30.1  95.4  28.4  94.7

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists seven outcome measures, including the primary TEAE count and six pharmacokinetic outcomes. It does not report a multiplicity plan describing how the chance of false-positive findings across multiple outcomes would be handled. No statistical analyses are listed in the record, and no inferential results are reported for the primary outcome. It is therefore not possible to determine whether any planned multiplicity adjustment was used or whether the outcomes were intended to be interpreted hierarchically.

Missing-data methods and analysis populations are not reported in the registry record. The primary results include group sizes for the groups with posted values, but the record does not explain whether these are all randomized participants, treated participants, participants with an available assessment, or another analysis population. It does not describe how missing endpoint assessments, withdrawals, or protocol deviations were handled. The enrollment figure alone does not identify which participants contributed to each outcome.

The record also does not report an intention-to-treat definition, a safety population definition, or a pharmacokinetic analysis population. The posted primary outcome values are available for Kindolor Cohorts 1 and 2 and the placebo comparator, while values for Kindolor Cohorts 3 and 4 are not reported in the primary results. The reason those results are absent is not reported in the registry record. These gaps limit interpretation of the completeness of outcome reporting and the population represented by each analysis.

General statistical context: missingness can affect both the precision and the interpretation of a result, particularly when the chance that an outcome is unobserved is related to the participant’s health or treatment experience. Without information on the amount, reasons, and handling of missing data, readers cannot assess whether the posted counts may be affected by such processes.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry safety information reports serious adverse events separately from the primary count of participants with any treatment-emergent adverse event. For serious adverse events, the posted figures are 0 affected participants among 6 at risk in Kindolor Cohort 1, 0 among 6 at risk in Kindolor Cohort 2, and 0 among 4 at risk in the placebo comparator. The record reports 0 deaths in each of those groups. Serious adverse-event terms are not listed.

These figures mean that no serious adverse events or deaths were recorded in the reported groups during the safety information summarized in the registry. They do not establish that the risk of a serious event is absent. General statistical context: when no events are observed, uncertainty remains about the underlying event risk, and a limited study may not detect uncommon events. The registry record does not report serious adverse-event results for Kindolor Cohorts 3 and 4.

The separate figures for other adverse events are 6 affected participants in Kindolor Cohort 1, 6 in Kindolor Cohort 2, and 3 in the placebo comparator. These counts should not be conflated with serious adverse events, nor should they be interpreted as counts of event episodes. The registry does not provide further event-level detail in the posted summary.

13. What the Result Does, and Does Not, Mean

The posted primary results describe treatment-emergent adverse events in the reported groups of healthy adults. They show 6 participants with TEAEs in Kindolor Cohort 1, 6 in Kindolor Cohort 2, and 3 in the placebo comparator. Serious adverse events and deaths are reported as 0 in each reported group. These observations are descriptive; the registry record does not report an inferential comparison, confidence intervals, or a formal test of differences between Kindolor and placebo.

The results do not establish that Kindolor caused the reported events, nor do they establish that the treatment groups have equivalent safety. A placebo group provides a comparator, but the posted counts alone do not account for uncertainty or other features of the study. The record does not provide event-level details about the nature, severity, duration, or timing of the reported non-serious events. No conclusion about the full safety profile can be drawn from the primary count alone.

The registry record lists four Kindolor cohorts, but primary endpoint results are posted for only Kindolor Cohorts 1 and 2. The posted information therefore does not permit a description of the primary endpoint across every listed dose cohort or a dose-response interpretation. The wording of the dose descriptions for Kindolor Cohorts 3 and 4 is also not clear enough to resolve the intended dose interpretation.

The study was conducted in healthy adults, and its findings should not be treated as direct evidence about people with chronic pain. The record’s stated study questions concern safety and pharmacokinetics, not clinical benefit for a pain condition. The six listed pharmacokinetic outcomes have no numerical results in the record analyzed. Consequently, no statement about drug exposure, metabolism, or a relationship between exposure and adverse events is supported by the posted results.

In short, the registry supports a limited descriptive account of the primary outcome counts and the reported serious adverse-event figures. It does not support a claim of treatment benefit, a definitive comparative safety conclusion, or extrapolation to unreported cohorts or populations.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of the limits of interpreting early-phase safety counts. A participant-level endpoint is straightforward to read, and the registry gives both the event count and group size for the groups with posted results. At the same time, the study’s reported values are descriptive and no formal comparison or uncertainty interval is reported. Readers therefore need to distinguish observed counts from estimates of how groups differ in a broader population.

The design also illustrates why the scope of the analyzed data matters. The registry describes four Kindolor cohorts, but primary outcome values are available only for Kindolor Cohorts 1 and 2, along with the placebo comparator. Without primary results for the other listed cohorts, the posted results do not establish a pattern across the full set of dose groups. The dose descriptions for the later cohorts are also ambiguous in the record, which makes dose-based interpretation especially limited.

The record lists pharmacokinetic outcomes alongside safety outcomes, reflecting the study’s stated interest in how Kindolor is handled by the body. However, no numerical pharmacokinetic results are reported in the record analyzed. That gap prevents readers from relating exposure measures to the reported adverse-event counts.

Finally, the posted record makes clear why reporting analysis populations, missing-data handling, and a statistical analysis plan is important. Without those details, readers cannot fully assess who contributed to each outcome, how incomplete assessments were treated, or whether analyses were planned to account for multiple outcomes. These are not reasons to dismiss the descriptive data; they define what the data can and cannot support.

15. 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 has important limitations for interpreting this study’s primary result. Although it describes four Kindolor cohorts, the posted primary outcome includes results only for Kindolor Cohorts 1 and 2 and the placebo comparator. Primary results for Kindolor Cohorts 3 and 4 are not reported in the registry record. The reason for their absence is not stated. The dose descriptions for those cohorts are also difficult to interpret from the registry wording, limiting dose-specific discussion.

The posted results do not include confidence intervals, hypothesis tests, or a formal comparison of the primary endpoint between Kindolor and placebo. The record marks the two-arm comparison as not estimable from the available binary endpoint values. As a result, the relative precision of the observed group counts cannot be assessed from the posted statistical results. No discrepancy is flagged, but no sponsor analysis is reported for this endpoint either.

Further limitations include the absence of reported analysis populations, missing-data methods, and details about protocol deviations or withdrawals. The record does not explain whether the group sizes in the primary results represent all randomized participants or a subset with available assessments. The reason for study termination is not reported in the registry record.

The record lists pharmacokinetic outcomes but does not report their numerical results or analysis methods. It also does not describe event-level details for the non-serious adverse events. The study’s stated population is healthy adults, so the registry record does not support generalizing the reported counts to people with chronic pain. These limitations constrain interpretation to the posted descriptive safety information.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study to Test the Effects of Kindolor at Different Doses in Healthy Adults — NCT06243835.
• Registry record last updated 2026-05-27; status last verified 2026-03.
• Results first posted 2026-05-27.
• 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.

19. Record Summary

The registry record describes NCT06243835, a randomized, double-blind, placebo-controlled, single-site Phase 1a study of Kindolor Tosylate in healthy adults. Enrollment was 16. The study started on 2024-04-21, reached primary completion on 2024-11-22, and is listed as terminated. The reason for termination is not reported in the registry record.

The primary outcome is the number of participants with TEAEs from Day 1 to Day 7. Results are posted for Kindolor Cohort 1, Kindolor Cohort 2, and the placebo comparator; primary results for Kindolor Cohorts 3 and 4 are not reported. The record lists six pharmacokinetic outcomes but does not report their numerical results. It lists no statistical analyses, and a two-arm comparison of the binary primary endpoint is marked as not estimable from the available values.

The reported data support a descriptive account of the posted safety counts, not a formal comparative conclusion. Analysis populations, missing-data handling, and a detailed statistical plan are not reported in the registry record.