A Phase I Clinical Trial to Evaluate CMS-F021 Following Single and Multiple Doses in Healthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorDermavon Holdings Limited
About this trial
"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 criteria
This trial accepts healthy volunteersQualifiers
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;
Age between 18 and 55 years (inclusive of boundary values, based on the date of signing the informed consent form), male or female;
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;
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.
Disqualifiers
Those with a history of allergy or allergic constitution;
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;
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;
Trial design
Design model
Parallel
Treatments tested in this trial
CMS-F021 Gel
DrugSingle Dose
Drug: CMS-F021 Placebo Gel healthy participant
DrugSingle Dose
Drug: CMS-F021 Gel healthy participant
DrugMultiple Dose
"Drug: CMS-F021 Placebo Gel healthy participant"
DrugMultiple Dose
Treatment groups
72 Participants
are divided into 4 treatment groupsGroup A: "Experimental: Single Dose Escalation of CMS-F021 5 sequential dose escalation cohorts - participantActive comparator 1 intervention
Group B: "Experimental: Single Dose Escalation of placebo 5 sequential dose escalation cohorts - parPlacebo comparator 1 intervention
Group C: "Experimental: Multiple Dose Escalation of CMS-F021 4 sequential dose escalation cohorts - participaActive comparator 1 intervention
Group D: "Experimental: Multiple Dose Escalation of placebo 4 sequential dose escalation cohorts - participanPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 days2
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 days3
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 10days4
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 10daysSecondary outcomes
1
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-dose2
Tmax
Using non-compartmental analysis (NCA) to calculate the time to reach Cmax after drug administration
Time frame
Through 48 hours post-dose3
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-doseSponsors and contacts
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Source ClinicalTrials.gov