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Trial Radar IA
Lo studio clinico NCT07494175 per Healthy Adult Male è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants Fase I 6

Non ancora in arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07494175 è uno studio interventistico di Fase I volto a esaminare il trattamento per Healthy Adult Male, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 marzo 2026, con l'obiettivo di raggiungere 6 partecipanti. Sotto la guida di HENGRUI PHARMA, dovrebbe concludersi entro il 1 aprile 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
To evaluate the absorption, metabolism and excretion after a single intravenous bolus of \[14C\]HRS-9190 in healthy Participants
Titolo ufficiale

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

Patologie
Healthy Adult Male
Altri ID dello studio
  • HRS-9190-103
Numero NCT
NCT07494175
Data di inizio (effettiva)
2026-03
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2026-04
Arruolamento (previsto)
6
Tipo di studio
Interventistico
FASE
Fase I
Stato
Non ancora in arruolamento
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleTreatment group A: [14C] HRS-9190
[14C] HRS-9190
\[14C\] HRS-9190 for injection
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Adverse events
up to 13 days postdose
Plasma concentration of HRS-9190 (metabolites, if necessary)
From 0 to 120 hours after dosing
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto
Età minima
18 Years
Sessi idonei
Maschio
Accetta volontari sani
Sì
  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 studi clinici attivi da esplorare
Contatti principali dello studio
Contatto: Yuanyuan Huang, +0518-81220121, [email protected]
1 Centri dello studio in 1 paesi

Shandong

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