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Активно (без набиране) Фаза 1 NCT07494175

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

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Healthy Adult Male

Спонсор: Jiangsu HengRui Medicine Co., Ltd.

Налично на: БГ
Обобщение
To evaluate the absorption, metabolism and excretion after a single intravenous bolus of \[14C\]HRS-9190 in healthy Participants
Кой може да участва
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.
Интервенции
[14C] HRS-9190
DRUG
Места на провеждане 1
Китай (1)
First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan , Shandong
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Само мъже
Минимална възраст
18 Years
Максимална възраст
45 Years
Здрави доброволци
Не
Начална дата
11.04.2026
Крайна дата
01.05.2026
Регистрационен номер
NCT07494175
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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