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Active (not recruiting) Phase 1 NCT07494175

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

Phase 1 – testing safety in a small group of people
Conditions: Healthy Adult Male

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

trial.available_in: БГ
Overview
To evaluate the absorption, metabolism and excretion after a single intravenous bolus of \[14C\]HRS-9190 in healthy Participants
Who can participate
Inclusion Criteria: 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. Exclusion Criteria: 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.
Interventions
[14C] HRS-9190
DRUG
Locations 1
China (1)
First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan , Shandong
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
18 Years
Maximum age
45 Years
Healthy volunteers
No
Start date
11.04.2026
Completion date
01.05.2026
Registry ID
NCT07494175
Source
clinicaltrials.gov
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