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."
研究概览
地位
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:HAN WU
- 电话号码:86-0755-82418801
- 邮箱:h.wu@cms.net.cn
学习地点
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Beijing、中国
- 招聘中
- Beijing Jishuitan Hospital,Capital Medical University
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
Participants must meet all of the following eligibility criteria to be enrolled in this study:
- 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.
Exclusion Criteria:
Any participant meeting any of the following exclusion criteria will not be eligible for enrollment:
- 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;
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:"Experimental: Single Dose Escalation of CMS-F021 5 sequential dose escalation cohorts - participant
"Drug: CMS-F021 Gel healthy participant"
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Single Dose
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安慰剂比较:"Experimental: Single Dose Escalation of placebo 5 sequential dose escalation cohorts - par
"Drug: CMS-F021 Placebo Gel healthy participant"
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Single Dose
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有源比较器:"Experimental: Multiple Dose Escalation of CMS-F021 4 sequential dose escalation cohorts - participa
"Drug: CMS-F021 Gel healthy participant"
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Multiple Dose
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安慰剂比较:"Experimental: Multiple Dose Escalation of placebo 4 sequential dose escalation cohorts - participan
"Drug: CMS-F021 Placebo Gel healthy participant"
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Multiple Dose
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline to each visit point in vital signs (temperature, blood pressure, heart rate, respiratory rate)
大体时间:through study completion,an average of 4 days or 10 days
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Measured using electronic sphygmomanometer/thermometer according to standard procedures, record actual values at each visit point, and assess abnormal values.
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through study completion,an average of 4 days or 10 days
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Incidence rate of abnormal findings in comprehensive systemic physical examination
大体时间:through study completion,an average of 4 days or 10 days
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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.
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through study completion,an average of 4 days or 10 days
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Hematology, biochemistry, urinalysis ,and Coagulation Profilelaboratory test indicators
大体时间:through study completion,an average of 4 days or 10days
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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.
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through study completion,an average of 4 days or 10days
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12-lead electrocardiogram QTc interval, heart rate, and incidence of morphological abnormalities
大体时间:through study completion,an average of 4 days or 10days
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Collected using standard 12-lead ECG equipment,with the number and incidence rate of QTc interval changes, heart rate abnormalities, and morphological abnormalities summarized.
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through study completion,an average of 4 days or 10days
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Skin Irritation Score
大体时间:through study completion,an average of 4 days or 10days
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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).
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through study completion,an average of 4 days or 10days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Maximum plasma drug concentration (Cmax)
大体时间:Through 48 hours post-dose
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Calculate the maximum observed plasma concentration from the plasma drug concentration-time curve after administration using non-compartmental analysis (NCA)
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Through 48 hours post-dose
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Tmax
大体时间:Through 48 hours post-dose
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Using non-compartmental analysis (NCA) to calculate the time to reach Cmax after drug administration
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Through 48 hours post-dose
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Area under the curve (AUC0-t)
大体时间:Through 48 hours post-dose
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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)
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Through 48 hours post-dose
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合作者和调查者
调查人员
- 首席研究员:MEIXIA WANG、Beijing Jishuitan Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- F021-01-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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