A Phase I Clinical Trial to Evaluate CMS-F021 Following Single and Multiple Doses in Healthy Participants
Condition(s) studied
Investigational drug(s) / intervention(s)
CMS-F021 Gel: Single Dose
Drug: CMS-F021 Placebo Gel healthy participant: Single Dose
Drug: CMS-F021 Gel healthy participant: Multiple Dose
"Drug: CMS-F021 Placebo Gel healthy participant": Multiple Dose
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."
Eligibility
Primary outcome measure(s)
- Change from baseline to each visit point in vital signs (temperature, blood pressure, heart rate, respiratory rate) — through study completion,an average of 4 days or 10 days
Measured using electronic sphygmomanometer/thermometer according to standard procedures, record actual values at each visit point, and assess abnormal values. - Incidence rate of abnormal findings in comprehensive systemic physical examination — through study completion,an average of 4 days or 10 days
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. - Hematology, biochemistry, urinalysis ,and Coagulation Profilelaboratory test indicators — through study completion,an average of 4 days or 10days
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. - 12-lead electrocardiogram QTc interval, heart rate, and incidence of morphological abnormalities — through study completion,an average of 4 days or 10days
Collected using standard 12-lead ECG equipment,with the number and incidence rate of QTc interval changes, heart rate abnormalities, and morphological abnormalities summarized. - Skin Irritation Score — through study completion,an average of 4 days or 10days
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).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Jishuitan Hospital,Capital Medical University | Beijing | China | Recruiting |
More Dermavon Holdings Limited trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07790770 on ClinicalTrials.gov ↗ ← All trials in China