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Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants Phase 1 6

Noch nicht rekrutierend
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07494175 untersucht Behandlung im Zusammenhang mit Healthy Adult Male. Diese interventionsstudie der Phase 1 hat den Status noch nicht rekrutierend. Der Start ist für 1. März 2026 geplant, bis 6 Teilnehmer aufgenommen werden. Durchgeführt von HENGRUI PHARMA wird der Abschluss für 1. April 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. März 2026 aktualisiert.
Kurzbeschreibung
To evaluate the absorption, metabolism and excretion after a single intravenous bolus of \[14C\]HRS-9190 in healthy Participants
Offizieller Titel

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

Erkrankungen
Healthy Adult Male
Weitere Studien-IDs
  • HRS-9190-103
NCT-Nummer
NCT07494175
Studienbeginn (tatsächlich)
2026-03
Zuletzt aktualisiert
2026-03-27
Studienende (vorauss.)
2026-04
Geplante Rekrutierung
6
Studientyp
Interventionsstudie
PHASE
Phase 1
Status
Noch nicht rekrutierend
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellTreatment group A: [14C] HRS-9190
[14C] HRS-9190
\[14C\] HRS-9190 for injection
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Adverse events
up to 13 days postdose
Plasma concentration of HRS-9190 (metabolites, if necessary)
From 0 to 120 hours after dosing
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Männlich
Akzeptiert gesunde Freiwillige
Ja
  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 aktive klinische Studien zum Erkunden
Zentrale Studienkontakte
Kontakt: Yuanyuan Huang, +0518-81220121, [email protected]
1 Studienstandorte in 1 Ländern

Shandong

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