NCT06819488已完成1 期
A Clinical Study of Mass Balance of [14C]HRS-7535 in Healthy Adult Chinese Subjects
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年2月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The total radioactivity ratio for plasma
研究概览
简要总结
The objective is to evaluate the mass balance of [14C]HRS-7535 in healthy adult Chinese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects must voluntarily sign the informed consent form (ICF) prior to any activities related to the study, demonstrate understanding of the study procedures and methods, and commit to strictly adhering to the clinical trial protocol to complete the study.
- •Healthy male subjects aged between 18 and 45 years (inclusive), determined at the time of signing the informed consent.
- •Male subjects must weigh ≥ 50 kg and have a body mass index (BMI) between 19 and 26 kg/m² (inclusive).
- •Male subjects with female partners of childbearing potential must have no plans for procreation or sperm donation from the time of signing the informed consent until one year after the last dose of the study drug. They must also agree to use highly effective contraception methods (including their partners) during this period.
排除标准
- •Subjects with abnormalities identified through a comprehensive physical examination, vital signs assessment, laboratory tests, chest X-ray, 12-lead ECG, or abdominal ultrasound that are deemed clinically significant by the investigator.
- •Subjects with QTcF ≥ 450 msec at screening or baseline, or any other abnormalities considered clinically significant by the investigator.
- •Subjects who test positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antigen/antibody combination, or syphilis-specific antibodies.
- •Subjects with a history of drug abuse, drug dependence (based on medical history), or those who test positive for drug abuse during urine screening prior to dosing.
- •Subjects who have used any prescription drugs, over-the-counter medications, herbal medicines, or dietary supplements within 2 weeks prior to screening.
研究组 & 干预措施
[14C]HRS-7535
Experimental
干预措施: [14C]HRS-7535 (Drug)
结局指标
主要结局
The total radioactivity ratio for plasma
时间窗: 0-96 hours.
The terminal half-life (t1/2)
时间窗: 0-120 hours.
The time of maximum observed concentration (Tmax)
时间窗: 0-120 hours.
The maximum observed concentration (Cmax)
时间窗: 0-120 hours.
The total body clearance for extravascular administration (CL/F)
时间窗: 0-120 hours.
The total radioactivity ratio for blood
时间窗: 0-96 hours.
次要结局
- Adverse events (AEs)(0-11 days.)
- Serious adverse events (AEs)(0-11 days.)
研究者
研究点 (1)
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