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A Single Ascending Dose Study Of CY150112 After Single Oral Administration in Healthy Chinese Subjects

7 de abril de 2021 atualizado por: Jiangsu Nhwa Pharmaceutical Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of CY150112 After Single Oral Administration in Healthy Chinese Subjects

The primary objective of single ascending dose study is to evaluate the safety and tolerability of CY150112 after single oral administration of different doses in healthy Chinese subjects.

Visão geral do estudo

Descrição detalhada

Single administration, double-blinded, placebo-controlled (2 subjects in each group will take placebo,8 subjects in each group will take CY150112) and 6 dose groups (0.5mg, 1.5mg, 4.5mg, 10mg, 18mg and 24mg).

This study comprises a screening period (between signing of the informed consent form and Day -1), baseline period (Day -1), treatment period (Days 1-5) and follow-up period(Days 12 or 7 days after discharge ).

Tipo de estudo

Intervencional

Inscrição (Antecipado)

60

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Hua Fang li, MD
  • Número de telefone: 021-34773107
  • E-mail: lhlh_5@163.com

Estude backup de contato

  • Nome: Li Yan, Research Doctor
  • Número de telefone: 021-34773107
  • E-mail: lhlh_5@163.com

Locais de estudo

    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recrutamento
        • Shanghai Mental Health Center
        • Contato:
          • Hua Fang li, MD
          • Número de telefone: 021-34773107
          • E-mail: lhlh_5@163.com
        • Contato:
          • Li Yan, Research Doctor
          • Número de telefone: 021-34773107
          • E-mail: lhlh_5@163.com
        • Investigador principal:
          • Hua Fang Li, MD
        • Subinvestigador:
          • Li Yan, Research Doctor

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 45 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Male/female subjects are 18<age ≤45 years of age when signing the informed consent.
  2. Male Subjects with body weight of ≥50.0kg ,and female Subjects with body weight of ≥45.0kg and BMI (body mass index) of 18.5≤ and <28.0 at screening examination.
  3. After detailed explanations of study objectives, contents and procedures, and possible risks, subjects are aware of all relevant information related to this study and have signed the written informed consent form voluntarily.
  4. Subjects are able to communicate well with researchers, be willing and able to comply with the lifestyle restrictions stipulated during this study period, and cooperate to complete this study.

Exclusion Criteria:

  1. The investigator determined that the subjects' present medical history and past medical history had any disease or dysfunction that would affect the clinical trial, including but not limited to diseases of the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, hematological system, etc.
  2. There is any surgical condition or disease that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or may harm to the subjects participating in the trial; such as history of gastrointestinal operations (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, digestive tract ulcers, history of gastrointestinal bleeding, etc.
  3. Subjects with past history of allergy to drugs or allergic disease.
  4. Subjects with currently or past history of mental disorders and brain functional disorders.
  5. According to the Columbia suicide severity scale (C-SSRS), subjects were at risk of suicide or were at risk of suicide based on the clinical judgment of the researchers, or with past history of self-injurious behavior.
  6. Subjects have history of drug abuse or positive urine drug tests at screening within 1 year prior.
  7. Subjects have history of alcohol abuse(i.e.,criteria are per week consumption more than 14 standard units(1 unit =360mL beer or 45mL 40% alcohol of Chinese liquor or 150mL wine)or positive alcohol breath tests at screening within 1 year prior.
  8. Average amount of daily smoking>5 cigarettes at screening 3 months prior.
  9. Those who have special requirements for food, cannot follow a uniform diet or have difficulty swallowing.
  10. Female subjects who are pregnant and lactating ; and those who refuse to use effective non-drug contraceptive measures (such as abstinence, intrauterine device) or have planned to donate sperm or ovum throughout the study period and within 3 months after the end of the study.
  11. Abnormal vital signs, lab and ECG indicators, as determined by the researcher, and clinically significant (e.g., male QTC > 450ms female > 470ms,corrected by Friericia ).
  12. Subjects who resting heart rate <55 beats/min or >100 beats/min; systolic blood pressure <90mmHg or >140mmHg; diastolic blood pressure <60mmHg or >90mmHg.
  13. Subjects who hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or HIV antibody (HIV-Ab), or syphilis serum reaction (TRUST) is non-negative.
  14. Subjects who glutamic-pyruvic transaminase(ALT), creatinine (Cr), urea nitrogen (BUN) exceeding the normal upper limit or the level of serum prolactin is 2 times higher than the normal upper limit.
  15. Subjects who participated in any clinical trial within 3 months before medication.
  16. Subjects have history of blood donations of 400 mL within 3 months before enrollment; 200 mL within 1 month before enrollment; or have history of using blood products.
  17. Subjects who had a history of surgery within 3 months prior to enrollment, or did not recover from surgery, or had an expected surgical plan during the study period.
  18. Subjects who had taken any drugs, including prescription and over-the-counter drugs within 2 weeks prior to enrollment.
  19. Subjects who directly related to this clinical trial.
  20. Subjects have poor compliance or other problems that the researchers believe that it is not suitable for participating.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 0.5mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Outros nomes:
  • placebo
Experimental: 1.5mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Outros nomes:
  • placebo
Experimental: 4.5mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Outros nomes:
  • placebo
Experimental: 10mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Outros nomes:
  • placebo
Experimental: 18mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Outros nomes:
  • placebo
Experimental: 24mg CY150112
single oral CY150112 while fasting on day 1.
single oral CY150112 while fasting on day 1.
Outros nomes:
  • placebo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Incidence of AEs
Prazo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Incidence of Adverse Events
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Cmax
Prazo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Maximum (peak) observed drug serum concentration
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
AUC0-t
Prazo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Area under the concentration-time curve from time zero (pre-dose) to the time of the dosing interval
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
AUC0-∞
Prazo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
%AUCex
Prazo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Extrapolation percentage of AUC0-∞
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Tmax
Prazo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Time of occurrence of Cmax
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
T1/2
Prazo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Vd
Prazo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Apparent volume of distribution
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
CL
Prazo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Clearance
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
λz
Prazo: pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose
Elimination rate constant
pre-dose(within1hour),0.25,0.5,1,1.5,2,2.5,3,4,6,8,12,24,48,96hours post-dose

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Hua Fang li, MD, Shanghai Mental Health Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

2 de março de 2021

Conclusão Primária (Antecipado)

1 de agosto de 2021

Conclusão do estudo (Antecipado)

1 de agosto de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

6 de abril de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de abril de 2021

Primeira postagem (Real)

9 de abril de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de abril de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de abril de 2021

Última verificação

1 de abril de 2021

Mais Informações

Termos relacionados a este estudo

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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