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- Ensaio Clínico NCT05328583
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral HRS5685 in Healthy Subjects
A Phase I Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral HRS5685 in Healthy Subjects
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Liping Ma
- Número de telefone: 0518-82342973
- E-mail: liping.ma@hengrui.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Able and willing to provide written informed consent and to comply with the study protocol;
- Must be 18 to 45 years of age (inclusive);
- Body weight of at least 50 kg for male, and 45 kg for female; and Body Mass Index (BMI) within the range of 18 to 28 kg/m2 (inclusive);
- Physical examination, vital signs, laboratory tests, 12-lead ECG, eGFR (CKD-EPI formula), abdominal ultrasound and chest radiograph are normal or are judged not clinically significant by the investigator;
- Subjects (including partners) of childbearing potential are willing to useprotocol specified effective methods of contraception from screening to at least 8 months (for female) or 6 months (for male) after the final dose of study drug;
Exclusion Criteria:
- History or presence of any clinically significant cardiovascular, endocrine, neurological, gastrointestinal, respiratory, hematological, immunological, psychiatric, metabolic disorders or any diseases that may interfere with the study results;
- Subjects with severe infections, severe trauma or major surgical operation within 3 months before drug administration; or subjects plan to undergo surgery during the trial and within two weeks after the end of trial;
- Abnormal ECG that is clinically significant, or QTcF< 300 msec or >450 msec for men and >460 msec for women;
- Positive test result of any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis, or human immunodeficiency virus (HIV) antibody;
- Suspected allergy to any ingredient in the study drug;
- Use of any drug that inhibits or induces hepatic metabolism within 1 month prior to the first dose of study drug;
- Any condition or disease that affects the absorption, metabolism, and/or excretion of the study drug as judged by the investigator;
- Use of any prescription or over-the-counter medication, including herbal medications within 1 month prior to the first dose of study drug;
- Participation in clinical trials of any drug or medical device (except for screening failures) within 3 months before screening, or within 5 half-lives of the drug at screening (whichever is longer);
- Receiving vaccine(s) within 1 month prior to the first dose of study drug;
- Donation or loss of blood of ≥ 200 mL within 1 month or of ≥ 400 mL within 3 months prior to the first dose of study drug; or receiving blood transfusion within 8 weeks prior to the first dose of study drug; or have difficulty in venous blood collection, or whose physical condition cannot withstand intensive blood sampling;
- An average daily smoking of ≥ 5 cigarettes or an average daily alcohol intake of 15 g (15 g alcohol is equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol liquor) within 3 months before screening;
- Subjects who cannot refrain from smoking and alcohol intake from 2 days before the start of study treatment until the last follow-up;
- Subjects who consume alcoholic beverages, Seville oranges, grapefruit or juices, or products containing caffeine or xanthine (such as coffee, tea, cola drinks and chocolate) from 2 days before the start of study treatment, and those who have special dietary requirements and cannot comply with the unified diet;
- Subjects with a history of drug abuse, drug dependence, or a positive drugs of abuse test, or a positive alcohol breath test before study drug administration;
- Pregnant or lactating females;
- Other conditions judged by the investigator to be not suitable to participate in the trial;
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Treatment group A(Part A)
Drug1: HRS5685, dose 1; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Experimental: Treatment group B(Part A)
Drug1: HRS5685, dose 2; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Experimental: Treatment group C(Part A)
Drug1: HRS5685, dose 3; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Experimental: Treatment group D(Part A)
Drug1: HRS5685, dose 4; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Experimental: Treatment group E(Part A)
Drug1: HRS5685, dose 5; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Experimental: Treatment group F(Part A)
Drug1: HRS5685, dose 6; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Experimental: Treatment group G(Part B)
Drug1: HRS5685, dose 3; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
|
Experimental: Treatment group H(Part B)
Drug1: HRS5685, dose 4; Drug2: Placebo
|
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Safety and tolerability: Incidence and severity of adverse events
Prazo: Up to Day 63 after the last dose
|
Up to Day 63 after the last dose
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Area under the concentration-time curve during a dosing interval (AUCtau),
Prazo: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t)
Prazo: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Area under the concentration-time curve extrapolated to infinity (AUC0-inf )
Prazo: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Maximum observed concentration (Cmax)
Prazo: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Time to Maximum observed concentration (Tmax)
Prazo: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Half-life (t1/2),
Prazo: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Apparent clearance (CL/F)
Prazo: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Apparent volume of distribution (Vz/F)
Prazo: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Trough concentration (Ctrough)
Prazo: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Accumulation ratio (Rac),
Prazo: Pre-dose up to Day 63 after the last dose
|
Pre-dose up to Day 63 after the last dose
|
|
Renal clearance (CLr)
Prazo: Pre-dose up to 72 hours post-dose
|
Pre-dose up to 72 hours post-dose
|
|
Cumulative amount of drug excreted (Ae)
Prazo: Pre-dose up to 72 hours post-dose
|
Pre-dose up to 72 hours post-dose
|
|
Cumulative percentage of dose recovered (fe)
Prazo: Pre-dose up to 72 hours post-dose
|
Pre-dose up to 72 hours post-dose
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Termos MeSH relevantes adicionais
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções transmitidas pelo sangue
- Doenças Transmissíveis
- Doenças Sexualmente Transmissíveis, Virais
- Doenças Sexualmente Transmissíveis
- Infecções por Lentivírus
- Infecções por Retroviridae
- Síndromes de Deficiência Imunológica
- Doenças do sistema imunológico
- Doenças de Vírus Lento
- Infecções por HIV
- Síndrome da Imunodeficiência Adquirida
Outros números de identificação do estudo
- HRS5685-101
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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