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O estudo clínico NCT07489482 para Diabetes mellitus está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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A Clinical Study Comparing the Relative Bioavailability and Safety of SHR-3167 Injection Fase I 60 Randomizado Estudo aberto

Ainda não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07489482 vai avaliar tratamento para Diabetes mellitus. Este é um estudo intervencionista de Fase I. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de março de 2026, com o objetivo de incluir 60 participantes. Coordenado por HENGRUI PHARMA e deve ser concluído em 1 de dezembro de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 24 de março de 2026.
Resumo
This study is a randomized, parallel, open-label Phase I clinical trial aimed at comparing the bioavailability and safety of different specifications of SHR-3167 injection, with healthy subjects as the research subjects.
Título oficial

A Randomized, Parallel, Open-label Clinical Study on the Bioavailability and Safety of Different Specifications of SHR-3167 Injection in Healthy Subjects

Condições médicas
Diabetes mellitus
Outros IDs do estudo
  • SHR-3167-106
Número NCT
NCT07489482
Data de início (real)
2026-03
Última atualização postada
2026-03-24
Data de conclusão (estimada)
2026-12
Inscrição (estimada)
60
Tipo de estudo
Intervencionista
FASE
Fase I
Status
Ainda não recrutando
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalSHR-3167 Injection - Specification A Group
SHR-3167 Injection
SHR-3167 injection, different specifications.
ExperimentalSHR-3167 Injection - Specification B Group
SHR-3167 Injection
SHR-3167 injection, different specifications.
ExperimentalSHR-3167 Injection - Specification C Group
SHR-3167 Injection
SHR-3167 injection, different specifications.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
The maximum plasma concentration (Cmax)
Day 1 - Day 71.
The area under the blood drug concentration-time curve corresponding from time 0 to the last quantifiable concentration time (AUC0-t)
Day 1 - Day 71.
The area under the blood drug concentration-time curve from time 0 to infinity (AUC0-∞)
Day 1 - Day 71.
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Time to maximum plasma concentration (Tmax)
Day 1 - Day 71.
Terminal half-life (t1/2)
Day 1 - Day 71.
Apparent volume of distribution (Vz/F)
Day 1 - Day 71.
Safety: Incidence and severity of adverse events (AEs)
Day 1 - Day 71.
Anti-SHR-3167 antibody (ADA)
Day 1; Day 22; Day 71.
Apparent clearance (CL/F)
Day 1 - Day 71.
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
  1. Male or female: 18 years old to 55 years old (on the day of signing the informed consent form).
  2. For healthy subjects, the body mass index (BMI) should be between 19.0 kg/m² and 26.0 kg/m², and the weight of men should be ≥ 50 kg and that of women ≥ 45 kg.
  3. Those who show no abnormalities through physical examination, vital signs, 12-lead electrocardiogram, frontal and lateral chest radiographs and laboratory tests, or have minor abnormalities but are judged by the researcher to have no clinical significance.
  4. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must have no plans for conception or sperm/egg donation from the time of signing the informed consent form until 4 months after the last dose, and must voluntarily refrain from unprotected sexual activity within 14 days before the screening period and use effective contraceptive measures (including partners) during the study period; female subjects of childbearing potential must have no unprotected sexual activity in the past 14 days, have a negative pregnancy test during the screening period, and not be in the lactation period.
  5. During the screening process, the fasting blood glucose should be between 3.9 mmol/L and 6.1 mmol/L, and the glycated hemoglobin (HbA1c) should be no more than 6.0%.
  6. Understand the research procedures and methods, voluntarily participate and have the ability to comply with the requirements of the trial protocol to complete this trial, and sign the informed consent form in person.

  1. Those with a history of frequent allergies or allergic diseases, or those who, as judged by the researcher, may be allergic to the study drug or its components or foods, etc.
  2. Those who have previously suffered from respiratory system, circulatory system, digestive system, urinary system, mental, nervous system, blood system, endocrine system, immune system or malignant tumor diseases, and who, based on the investigator's judgment, are not suitable to participate in this trial.
  3. Exclude those who had severe infections, severe injuries or surgeries within the previous 12 weeks, or those who plan to undergo surgery during the trial.
  4. Exclude those who have participated in any clinical trials of other drugs or medical devices within the previous 3 months prior to screening, or those who are still within 5 half-lives of the trial drug at the time of screening (whichever is longer).
  5. Exclude those who have used any medication (including prescription drugs, over-the-counter drugs, herbal medicines, patent medicines, health supplements, etc.) within the previous 2 weeks up to the time of randomization.
  6. Positive results were obtained for hepatitis B surface antigen (HBsAg), HIV antibody, Treponema pallidum specific antibody, or hepatitis C virus antibody tests; or the investigator judged that the subject was in the latent or active stage of the aforementioned infections.
  7. Exclude those who have a history of blood donation within the past 12 weeks, or have suffered from severe blood loss (blood loss ≥ 400 mL), or have received blood transfusion within the past 12 weeks.
  8. Those who received live (attenuated) vaccines within the previous 1 month or are scheduled to receive such vaccines during the trial process.
  9. Those who have a history of drug use or substance abuse; or those who tested positive for drugs in the baseline visit.
  10. Those who have difficulty in venous blood collection or whose physical condition does not allow for blood collection; or those who are expected not to comply well with the protocol or complete the entire trial follow-up.
  11. Persons with incomplete civil capacity and without a valid guardian.
  12. The researchers determined that any physical or psychological condition or illness that might increase the risk of the trial, affect the subjects' compliance with the protocol, or prevent the subjects from completing the trial.
Jiangsu HengRui Medicine Co., Ltd. logoHENGRUI PHARMA143 estudos clínicos ativos para explorar
Contato central do estudo
Contato: Yanli Dong, +86-0518-82342973, [email protected]
Contato: Weijie Kong, +86-0518-82342973, [email protected]
1 Locais do estudo em 1 países

Hunan

Xiangya Hospital, Central South University, Changsha, Hunan, 410008, China
Gan Zhou, Contato, +86-0731-89753401, [email protected]
Gan Zhou, Investigador principal