Tiny radioactive tracer reveals Drug's journey through the body
NCT ID NCT07494175
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tracks a single injection of [14C]HRS-9190 in 6 healthy men to see how it is absorbed, broken down, and eliminated. The goal is to understand the drug's metabolism and excretion, not to treat any disease. Participants are closely monitored for side effects, but there is no expected health benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [14C]HRS-9190 (a radioactive-labeled drug for injection)
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
6 people
The number who actually took part.
- Started
-
Apr 2026
- Expected to finish
-
May 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
-
Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, 250014, China
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