drugset / Trial / NCT03229291

A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects

NCT03229291 ↗

Phase 1 Completed 24 enrolled Biosplice Therapeutics, Inc.
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

EvaluationDrugModalityDoseRoute
Subject SM04755 Small molecule 15 mg/ml Topical
Subject SM04755 Small molecule 45 mg/ml Topical
Subject SM04755 Small molecule 90 mg/ml Topical

Indications