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RECRUITING
NCT07790770
PHASE1

A Phase I Clinical Trial to Evaluate CMS-F021 Following Single and Multiple Doses in Healthy Participants

Sponsor: Dermavon Holdings Limited

View on ClinicalTrials.gov

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

DRUG

CMS-F021 Gel

Single Dose

DRUG

Drug: CMS-F021 Placebo Gel healthy participant

Single Dose

DRUG

Drug: CMS-F021 Gel healthy participant

Multiple Dose

DRUG

"Drug: CMS-F021 Placebo Gel healthy participant"

Multiple Dose

Locations (1)

Beijing Jishuitan Hospital,Capital Medical University

Beijing, China