A Phase 1 interventional study of CMS-F021 Gel and Drug: CMS-F021 Placebo Gel healthy participant in Superficial Skin and Soft Tissue Infections Caused by Gram-positive Bacteria, sponsored by Dermavon Holdings Limited. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Dermavon Holdings Limited · Phase 1, Interventional, and Treatment
"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."
92 studies on the registry are indexed under Soft Tissue Infections; 14 are open to participants now.
This study's planned enrollment of 72 is below the median of 123 across 58 interventional studies indexed under Soft Tissue Infections.
Browse Soft Tissue Infections studies →Dermavon Holdings Limited is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following eligibility criteria to be enrolled in this study:
Exclusion Criteria:
Any participant meeting any of the following exclusion criteria will not be eligible for enrollment:
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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
"Drug: CMS-F021 Gel healthy participant"
Drug: CMS-F021 Gel
"Drug: CMS-F021 Placebo Gel healthy participant"
Drug: Drug: CMS-F021 Placebo Gel healthy participant
"Drug: CMS-F021 Gel healthy participant"
Drug: Drug: CMS-F021 Gel healthy participant
"Drug: CMS-F021 Placebo Gel healthy participant"
Drug: "Drug: CMS-F021 Placebo Gel healthy participant"
Single Dose
Single Dose
Multiple Dose
Multiple Dose
Change from baseline to each visit point in vital signs (temperature, blood pressure, heart rate, respiratory rate)
Measured using electronic sphygmomanometer/thermometer according to standard procedures, record actual values at each visit point, and assess abnormal values.
Time frame: through study completion,an average of 4 days or 10 days
Incidence rate of abnormal findings in comprehensive systemic physical examination
Record abnormal physical examination findings by system (cardiovascular, respiratory, digestive, etc.), summarize the number and incidence rate of abnormalities in each system, and categorize them as related or unrelated to the study drug.
Time frame: through study completion,an average of 4 days or 10 days
Hematology, biochemistry, urinalysis ，and Coagulation Profilelaboratory test indicators
The tests include complete blood count (WBC, RBC, Hb, etc.), blood biochemistry (ALT, AST, Cr, etc.), urinalysis ，and Coagulation Profile; changes from baseline were calculated, and the incidence of abnormal values was summarized according to CTCAE 6.0 grading.
Time frame: through study completion,an average of 4 days or 10days
12-lead electrocardiogram QTc interval, heart rate, and incidence of morphological abnormalities
Collected using standard 12-lead ECG equipment,with the number and incidence rate of QTc interval changes, heart rate abnormalities, and morphological abnormalities summarized.
Time frame: through study completion,an average of 4 days or 10days
Skin Irritation Score
Skin reactions will be assessed using the skin irritation scoring scale specified in the FDA and CDE guidance documents, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs and Technical Guidance for Clinical Trials Evaluating Adhesion and Irritation/Sensitization of Transdermal and Topical Delivery Systems for Chemical Generic Drugs (Trial Implementation).
Time frame: through study completion,an average of 4 days or 10days
Maximum plasma drug concentration (Cmax)
Calculate the maximum observed plasma concentration from the plasma drug concentration-time curve after administration using non-compartmental analysis (NCA)
Time frame: Through 48 hours post-dose
Tmax
Using non-compartmental analysis (NCA) to calculate the time to reach Cmax after drug administration
Time frame: Through 48 hours post-dose
Area under the curve (AUC0-t)
Calculate the area under the concentration-time curve from time of administration (0 h) to the last quantifiable concentration time point (t) using non-compartmental analysis (NCA)
Time frame: Through 48 hours post-dose
Plan to share: No
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Dermavon Holdings Limited