drugset / Trial / NCT03229291
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2016-11-03
- Primary completion
- 2017-06-11
- Completion
- 2017-06-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SM04755 | Small molecule | 15 mg/ml | Topical |
| Subject | SM04755 | Small molecule | 45 mg/ml | Topical |
| Subject | SM04755 | Small molecule | 90 mg/ml | Topical |