Superficial Skin and Soft Tissue Infections Caused by Gram-positive Bacteria
Conditions
Brief 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."
Interventions
DRUGCMS-F021 Gel
Single Dose
DRUGDrug: CMS-F021 Placebo Gel healthy participant
Single Dose
DRUGDrug: CMS-F021 Gel healthy participant
Multiple Dose
DRUG"Drug: CMS-F021 Placebo Gel healthy participant"
Multiple Dose
Sponsors
Dermavon Holdings Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma drug concentration (Cmax) | Through 48 hours post-dose | Calculate the maximum observed plasma concentration from the plasma drug concentration-time curve after administration using non-compartmental analysis (NCA) |
| Tmax | Through 48 hours post-dose | Using non-compartmental analysis (NCA) to calculate the time to reach Cmax after drug administration |
| Area under the curve (AUC0-t) | Through 48 hours post-dose | 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) |
Countries
China
Contacts
CONTACTHAN WU
PRINCIPAL_INVESTIGATORMEIXIA WANG
Beijing Jishuitan Hospital
Outcome results
None listed