NCT07494175Active, not recruitingPhase 1

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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country6 target enrollmentStarted: April 11, 2026Last updated: April 24, 2026

Conditions

Interventions

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 6
Locations: 1
Primary Endpoint: Total radioactive pharmacokinetic parameter Tmax

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

To evaluate the absorption, metabolism and excretion after a single intravenous bolus of [14C]HRS-9190 in healthy Participants

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to 45 Years (Adult)
Sex: Male
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•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.
•Male participants aged between 18 and 45 years old (inclusive);
•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;
•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

•Participants with a history of or current acute or chronic clinical diseases
•Participants with a history of neuromuscular diseases;
•Participants with a history of anesthetic complications;
•Participants with a history of airway diseases;
•Participants who have undergone major surgery within 6 months prior to screening;
•During the screening or baseline period: participants with clinically significant abnormal physical examination findings as judged by the investigator;
•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);
•Participants with a known history of allergy to the study drug; a history of anaphylactic shock; or atopic diathesis;
•Participants with contraindications to anesthetic agents;
•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);
•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;
•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;
•Participants with difficult venous access;
•Occupational radiation workers; individuals with ≥2 CTs or ≥3 X-rays in the past year; participants in radiolabeled trials (within 1 year);
•Participants who may be unable to complete the study for other reasons or are deemed unsuitable for enrollment by the investigator.

Arms & Interventions

Treatment group A: [14C] HRS-9190

Experimental

Intervention: [14C] HRS-9190 (Drug)