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

NCT03229291 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-07-25

No results posted yet for this 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).

Conditions

  • Tendinopathy

Interventions

DRUG

SM04755

SM04755 is a small molecule inhibitor of the Wnt pathway.

DRUG

Vehicle

Same formulation as topical SM04755 solution, without SM04755 included.

Sponsors & Collaborators

  • Biosplice Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Yusuf Yazici, M.D. · Biosplice Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-03
Primary Completion
2017-06-11
Completion
2017-06-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03229291 on ClinicalTrials.gov