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O estudo clínico NCT07494175 para Healthy Adult Male 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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Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants Fase I 6

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 NCT07494175 vai avaliar tratamento para Healthy Adult Male. 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 6 participantes. Coordenado por HENGRUI PHARMA e deve ser concluído em 1 de abril de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 27 de março de 2026.
Resumo
To evaluate the absorption, metabolism and excretion after a single intravenous bolus of \[14C\]HRS-9190 in healthy Participants
Título oficial

Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants

Condições médicas
Healthy Adult Male
Outros IDs do estudo
  • HRS-9190-103
Número NCT
NCT07494175
Data de início (real)
2026-03
Última atualização postada
2026-03-27
Data de conclusão (estimada)
2026-04
Inscrição (estimada)
6
Tipo de estudo
Intervencionista
FASE
Fase I
Status
Ainda não recrutando
Propósito principal
Tratamento
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalTreatment group A: [14C] HRS-9190
[14C] HRS-9190
\[14C\] HRS-9190 for injection
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Total radioactive recovery rate and cumulative total radioactive recovery rate of excreta
From 0 to 120 hours after dosing
Percentage of unchanged HRS-9190 and its metabolites in the total radioactive exposure in plasma
From 0 to 120 hours after dosing
Percentage of unchanged HRS-9190 and its metabolites in urine and feces relative to the administered dose
From 0 to 120 hours after dosing
List of metabolites identified in plasma, urine, and feces
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Tmax
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Cmax
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter t1/2
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter MRT
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter AUC
From 0 to 120 hours after dosing
The whole blood-plasma radioactive distribution ratio
From 0 to 120 hours after dosing
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Adverse events
up to 13 days postdose
Plasma concentration of HRS-9190 (metabolites, if necessary)
From 0 to 120 hours after dosing
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Masculino
Aceita voluntários saudáveis
Sim
  1. The participants have been fully informed of the nature, significance, potential benefits, possible inconveniences, and potential risks and discomforts of the trial prior to its commencement.
  2. Male participants aged between 18 and 45 years old (inclusive);
  3. ASA =I;
  4. Male participants with a body weight of ≥ 50 kg and a body mass index (BMI = weight (kg)/height² (m²)) ranging from 19 to 28 kg/m² (inclusive) during the screening period;
  5. Male participants must agree to use highly effective contraception and refrain from donating semen from the time of signing the informed consent form until 4 months after the last administration of the investigational product.

  1. Participants with a history of or current acute or chronic clinical diseases
  2. Participants with a history of neuromuscular diseases;
  3. Participants with a history of anesthetic complications;
  4. Participants with a history of airway diseases;
  5. Participants who have undergone major surgery within 6 months prior to screening;
  6. During the screening or baseline period: participants with clinically significant abnormal physical examination findings as judged by the investigator;
  7. Participants who test positive for one or more of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), syphilis antibody, or human immunodeficiency virus antibody (anti-HIV);
  8. Participants with a known history of allergy to the study drug; a history of anaphylactic shock; or atopic diathesis;
  9. Participants with contraindications to anesthetic agents;
  10. Participants who use hepatic enzyme inhibitors/inducers (within 1 month prior to dosing), vaccines (within 1 month pre-screening or planned during trial), or any drugs/health products (within 7 half-lives or 14 days pre-dosing);
  11. Participants who have participated in other clinical trials and received investigational products within 3 months prior to screening, or plan to participate in other clinical trials during the trial period;
  12. Participants with history of significant blood loss/transfusion (≥400 mL within 3 months), active tobacco (>5 cigarettes/day), excessive alcohol/coffee consumption, use of interfering substances (e.g., grapefruit, caffeine) within 48h prior to dosing, or evidence of drug abuse;
  13. Participants with difficult venous access;
  14. Occupational radiation workers; individuals with ≥2 CTs or ≥3 X-rays in the past year; participants in radiolabeled trials (within 1 year);
  15. Participants who may be unable to complete the study for other reasons or are deemed unsuitable for enrollment by the investigator.
Jiangsu HengRui Medicine Co., Ltd. logoHENGRUI PHARMA143 estudos clínicos ativos para explorar
Contato central do estudo
Contato: Yuanyuan Huang, +0518-81220121, [email protected]
1 Locais do estudo em 1 países

Shandong

First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital), Jinan, Shandong, 250014, China
Wei Zhao, Investigador principal
Jianbo Wu, Investigador principal