Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase I Clinical Trial to Evaluate CMS-F021 Following Single and Multiple Doses in Healthy Participants
Sponsor: Dermavon Holdings Limited
Summary
"This study is a first-in-human (FIH) trial of CMS-F021 conducted in healthy Chinese adult participants, consisting of two parts: Part 1-a single ascending dose (SAD) study (referred to as Part 1 SAD), and Part 2-a multiple ascending dose (MAD) study (referred to as Part 2 MAD). The study aims to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics of CMS-F021 gel following single and multiple topical administrations in healthy Chinese adult participants. Both parts of the study are designed as randomized, double-blind, placebo controlled, sequential cohort trials. Part 1 SAD plans to include 5 dose cohorts,with 8 participants per cohort (6 receiving CMS-F021 and 2 receiving placebo),for a total of 40 participants. Part 2 MAD plans to include 4 dose cohorts, with 8 participants per cohort (6 receiving CMS-F021 and 2 receiving placebo), for a total of 32 participants."
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, PK Characteristics of CMS-F021 Following Single and Multiple Topical Administrations in Healthy Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2026-07-21
Completion Date
2027-03
Last Updated
2026-08-27
Healthy Volunteers
Yes
Interventions
CMS-F021 Gel
Single Dose
Drug: CMS-F021 Placebo Gel healthy participant
Single Dose
Drug: CMS-F021 Gel healthy participant
Multiple Dose
"Drug: CMS-F021 Placebo Gel healthy participant"
Multiple Dose
Locations (1)
Beijing Jishuitan Hospital,Capital Medical University
Beijing, China