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

NCT07790770 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-08-27

No results posted yet for this study

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."

Conditions

  • Superficial Skin and Soft Tissue Infections Caused by Gram-positive Bacteria

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

Sponsors & Collaborators

  • Dermavon Holdings Limited

    lead INDUSTRY

Principal Investigators

  • MEIXIA WANG · Beijing Jishuitan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-07-21
Primary Completion
2027-01-31
Completion
2027-03-31

Countries

  • China

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 NCT07790770 on ClinicalTrials.gov