Healthy Adult Male
Conditions
Brief summary
To evaluate the absorption, metabolism and excretion after a single intravenous bolus of \[14C\]HRS-9190 in healthy Participants
Interventions
DRUG[14C] HRS-9190
\[14C\] HRS-9190 for injection
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Adverse events | up to 13 days postdose |
| Plasma concentration of HRS-9190 (metabolites, if necessary) | From 0 to 120 hours after dosing |
Countries
China
Outcome results
None listed