Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 55

CMS-F021 gel safety test in healthy adults

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

Run by Dermavon Holdings Limited · NCT07790770 · Data updated 2026-11-12

This early-phase study tests a CMS-F021 gel to see if it is safe and tolerable when applied once or repeatedly on healthy Chinese adults.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 55 Years
SexAll
Enrollment72 (estimated)
SponsorDermavon Holdings Limited
Industry-sponsored
Locations1 site (Beijing)
StatusRecruiting
StartedJuly 21, 2026
Main results expectedJanuary 2027
Study endsMarch 2027
Registry record updatedAugust 27, 2026
Trial IDNCT07790770 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy adults aged 18-55 with BMI 19.0-26.0 kg/m2, weight thresholds, and no pregnancy plans, able to adhere to study requirements.

Probably not a fit

Participants who do not experience adverse safety signals or who do not develop useful pharmacokinetic data may not receive a direct benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, phase 1 trial evaluating CMS-F021 gel in healthy Chinese adults. It consists of two parts: a single ascending dose (SAD) section and a multiple ascending dose (MAD) section, both randomized and double-blind with placebo controls. Participants receive topical CMS-F021 or placebo in sequential cohorts to characterize safety, tolerability, and basic pharmacokinetics after single and multiple applications. The study plans 40 participants in Part 1 and 32 in Part 2, across multiple dose levels, at Beijing Jishuitan Hospital and Capital Medical University. Eligible adults are ages 18-55 with specific BMI and weight ranges, and there are strict contraception requirements.

Why it matters

Potential benefit: If successful, the gel could be shown to be safe for topical use in humans and may support further development for treating skin infections.

How similar studies have gone: Phase 1 topical gel studies in healthy volunteers often establish safety and PK profiles; this trial follows standard SAD/MAD designs used in early dermatology research.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Participants must meet all of the following eligibility criteria to be enrolled in this study:

1. Voluntarily participate in this study and sign the informed consent form, able to understand and comply with all requirements and restrictions of this study, and capable of completing the study according to the protocol;
2. Age between 18 and 55 years (inclusive of boundary values, based on the date of signing the informed consent form), male or female;
3. Body mass index (BMI) within the range of 19.0-26.0 kg/m² (inclusive of boundary values) at screening, with female weight ≥ 45.0 kg and male weight ≥ 50.0 kg;
4. Participants with reproductive potential (including their partners) must have no plans for pregnancy, egg donation, or sperm donation from the date of signing the informed consent form until 3 months after the last dose of study medication, and must strictly adhere to contraceptive measures during this period.

Exclusion Criteria:

Any participant meeting any of the following exclusion criteria will not be eligible for enrollment:

1. Those with a history of allergy or allergic constitution;
2. Abnormal vital signs, physical examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis), or 12-lead ECG findings at screening, judged by the investigator to have clinical significance;
3. History or clinical manifestations of significant diseases involving cardiovascular, respiratory, digestive, urinary/reproductive, hematologic, endocrine/metabolic, rheumatologic/immunologic, neurological/psychiatric, or musculoskeletal systems requiring medication and/or other treatments (including dietary restrictions and physical therapy), or considered by the investigator unsuitable for participation in this study; 4)Those with a history of severe skin diseases;

5\) Evidence of current acute skin infection, or history of recurrent or chronic severe skin infections; 6) Researchers believe there may be some skin conditions that could interfere with skin assessment; 7) Use of any prescription or non-prescription medication (including herbal medicines, vitamins, minerals, and dietary supplements) within 2 weeks before dosing or within at least five half-lives (whichever is longer); 8) Participation in any other clinical trial involving drugs or medical devices within 3 months prior to screening, or planning to participate in such trials during this study, or still within the 5 half-life window of a previous investigational agent (whichever is longer); 9) History of drug abuse within the past 6 months, or positive results in any drug abuse screening test; 10) Weekly alcohol consumption exceeding 14 units within the past 3 months (1 unit = 360 mL beer, 150 mL wine, or 45 mL spirits), or positive alcohol breath test result, or inability to abstain from alcohol during the study; 11) Average daily smoking of more than 5 cigarettes within the past 3 months, or inability to discontinue use of any tobacco products during the study; 12) Pregnant or breast feeding females; 13) Difficulty with venipuncture (e.g., history of needle phobia or fainting due to blood draw), or poor venous access deemed unsuitable by the investigator; 14) Blood donation or blood loss ≥ 400 mL within 3 months prior to screening, or receipt of blood transfusion or blood products, or plan to donate blood during the study period; 15) Any other condition determined by the investigator to be unsuitable for participation in this study.

Where it's running

  • Beijing Jishuitan Hospital,Capital Medical University
    Beijing, China
    Recruiting

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.