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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 is a Phase 1 study that has completed, run by Biosplice Therapeutics. The registered enrollment target is 24 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03229291
The ClinicalTrials.gov registry entry for NCT03229291 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biosplice Therapeutics, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT03229291 reports 0 study locations.
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.
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