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NCT03229291 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects
A Phase 1 study, sponsored by Biosplice Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03229291: Completed Phase 1 study, sponsored by Biosplice Therapeutics.
NCT03229291 is a Phase 1 study that has completed, run by Biosplice Therapeutics. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03229291, a Phase 1 study, has completed, sponsored by Biosplice Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study is a single-center, randomized, single-blind, placebo-controlled, multiple ascending dose study of SM04755 solution applied topically once daily for 14 days to intact skin overlying the inner thigh of healthy subjects at an estimated body surface area (BSA) of 80 cm\^2. Dosing cohorts will consist of 8 subjects who will be randomized 3:1 (SM04755:placebo).
Primary Outcome
Incidence and severity of AEs events during the treatment and observation periods of the study
Interventions
- DRUG Vehicle
- DRUG SM04755
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-11-03 |
| Est. Completion | 2017-06-11 |
| Phase | Phase 1 |
What the finished NCT03229291 record still lists
NCT03229291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT03229291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03229291 about?
NCT03229291 is a clinical study titled "A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects". This study is a single-center, randomized, single-blind, placebo-controlled, multiple ascending dose study of SM04755 solution applied topically once daily for 14 days to intact skin overlying the inner thigh of healthy subjects at an estimated body surface area (BSA) of 80 cm\^2. Dosing cohorts wil...
What is the current status of trial NCT03229291?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-11-03. Estimated completion is 2017-06-11.
What interventions are being tested in trial NCT03229291?
The interventions under investigation include: Vehicle (DRUG), SM04755 (DRUG).
Who is sponsoring clinical trial NCT03229291?
This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03229291's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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