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

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

"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."

Study Overview

• Status: Recruiting
• Conditions: Superficial Skin and Soft Tissue Infections Caused by Gram-positive Bacteria
• Intervention / Treatment: Drug: CMS-F021 Gel; Drug: Drug: CMS-F021 Placebo Gel healthy participant; Drug: Drug: CMS-F021 Gel healthy participant; Drug: "Drug: CMS-F021 Placebo Gel healthy participant"

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: HAN WU; Phone Number: 86-0755-82418801; Email: h.wu@cms.net.cn

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: "Experimental: Single Dose Escalation of CMS-F021 5 sequential dose escalation cohorts - participant; "Drug: CMS-F021 Gel healthy participant"	Drug: CMS-F021 Gel; Single Dose
Placebo Comparator: "Experimental: Single Dose Escalation of placebo 5 sequential dose escalation cohorts - par; "Drug: CMS-F021 Placebo Gel healthy participant"	Drug: Drug: CMS-F021 Placebo Gel healthy participant; Single Dose
Active Comparator: "Experimental: Multiple Dose Escalation of CMS-F021 4 sequential dose escalation cohorts - participa; "Drug: CMS-F021 Gel healthy participant"	Drug: Drug: CMS-F021 Gel healthy participant; Multiple Dose
Placebo Comparator: "Experimental: Multiple Dose Escalation of placebo 4 sequential dose escalation cohorts - participan; "Drug: CMS-F021 Placebo Gel healthy participant"	Drug: "Drug: CMS-F021 Placebo Gel healthy participant"; Multiple Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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).	through study completion,an average of 4 days or 10days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Through 48 hours post-dose
Tmax	Using non-compartmental analysis (NCA) to calculate the time to reach Cmax after drug administration	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)	Through 48 hours post-dose

Collaborators and Investigators

• Sponsor: Dermavon Holdings Limited
• Investigators: Principal Investigator: MEIXIA WANG, Beijing Jishuitan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: July 30, 2026
• First Submitted That Met QC Criteria: August 25, 2026
• First Posted (Actual): August 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: F021-01-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No