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

NCT07494175 | Active Not Recruiting Phase 1

• 1 other identifier: HRS-9190-103
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Male

Outcome Measures

Primary Outcomes (10)

• 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

Secondary Outcomes (2)

• Adverse events

  up to 13 days postdose

• Plasma concentration of HRS-9190 (metabolites, if necessary)

  From 0 to 120 hours after dosing

Study Arms (1)

Treatment group A: [14C] HRS-9190

EXPERIMENTAL

Drug: [14C] HRS-9190

Interventions

[14C] HRS-9190 DRUG

\[14C\] HRS-9190 for injection

Treatment group A: [14C] HRS-9190

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);
• ASA =I;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Jinan, Shandong, 250014, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 27, 2026
• Study Start: April 11, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-03

Locations

CN (1)