NCT03229291

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

A Phase 1, Single-Center, Randomized, Single-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Conditions

• Tendinopathy

Interventions

Type	Name	Description
DRUG	SM04755	SM04755 is a small molecule inhibitor of the Wnt pathway.
DRUG	Vehicle	Same formulation as topical SM04755 solution, without SM04755 included.

Timeline

• Start date: 2016-11-03
• Primary completion: 2017-06-11
• Completion: 2017-06-11
• First posted: 2017-07-25
• Last updated: 2017-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study