- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07790770
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."
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: HAN WU
- Número de telefone: 86-0755-82418801
- E-mail: h.wu@cms.net.cn
Locais de estudo
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Beijing, China
- Recrutamento
- Beijing Jishuitan Hospital,Capital Medical University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: "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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Comparador de Placebo: "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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Comparador Ativo: "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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Comparador de Placebo: "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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline to each visit point in vital signs (temperature, blood pressure, heart rate, respiratory rate)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).
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through study completion,an average of 4 days or 10days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Maximum plasma drug concentration (Cmax)
Prazo: 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
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: MEIXIA WANG, Beijing Jishuitan Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- F021-01-001
Plano para dados de participantes individuais (IPD)
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