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

2026년 8월 25일 업데이트: Dermavon Holdings Limited

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."

연구 개요

연구 유형

중재적

등록 (추정된)

72

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

      • Beijing, 중국
        • 모병
        • Beijing Jishuitan Hospital,Capital Medical University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: "Experimental: Single Dose Escalation of CMS-F021 5 sequential dose escalation cohorts - participant
"Drug: CMS-F021 Gel healthy participant"
Single Dose
위약 비교기: "Experimental: Single Dose Escalation of placebo 5 sequential dose escalation cohorts - par
"Drug: CMS-F021 Placebo Gel healthy participant"
Single Dose
활성 비교기: "Experimental: Multiple Dose Escalation of CMS-F021 4 sequential dose escalation cohorts - participa
"Drug: CMS-F021 Gel healthy participant"
Multiple Dose
위약 비교기: "Experimental: Multiple Dose Escalation of placebo 4 sequential dose escalation cohorts - participan
"Drug: CMS-F021 Placebo Gel healthy participant"
Multiple Dose

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline to each visit point in vital signs (temperature, blood pressure, heart rate, respiratory rate)
기간: 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.
through study completion,an average of 4 days or 10 days
Incidence rate of abnormal findings in comprehensive systemic physical examination
기간: 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.
through study completion,an average of 4 days or 10 days
Hematology, biochemistry, urinalysis ,and Coagulation Profilelaboratory test indicators
기간: 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.
through study completion,an average of 4 days or 10days
12-lead electrocardiogram QTc interval, heart rate, and incidence of morphological abnormalities
기간: 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.
through study completion,an average of 4 days or 10days
Skin Irritation Score
기간: 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).
through study completion,an average of 4 days or 10days

2차 결과 측정

결과 측정
측정값 설명
기간
Maximum plasma drug concentration (Cmax)
기간: 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)
Through 48 hours post-dose
Tmax
기간: Through 48 hours post-dose
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)
기간: 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)
Through 48 hours post-dose

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: MEIXIA WANG, Beijing Jishuitan Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 21일

기본 완료 (추정된)

2027년 1월 1일

연구 완료 (추정된)

2027년 3월 1일

연구 등록 날짜

최초 제출

2026년 7월 30일

QC 기준을 충족하는 최초 제출

2026년 8월 25일

처음 게시됨 (실제)

2026년 8월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 25일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • F021-01-001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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