NCT07025915尚未招募1 期
A Mass Balance Study of [14C]SSS17 in Healthy Chinese Male Subjects
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 6
- 主要终点
- Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces)
研究概览
简要总结
This study aims to evaluate the absorption, metabolism, and excretion of a single oral dose of [¹⁴C]SSS17 in healthy adult Chinese male subjects, elucidating its overall pharmacokinetic profile in humans to provide essential information for its rational clinical use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male subjects aged 18-45 years .
- •Body weight ≥50 kg .
- •Normal findings on comprehensive health assessment.
- •The subject demonstrates understanding of the trial's objectives, requirements, procedures, and potential adverse reactions; voluntarily participates; commits to complete all trial activities per protocol and comply with study regulations; with the informed consent process conducted in compliance with Good Clinical Practice ."
排除标准
- •Subjects with abnormalities in the nervous system, respiratory system, cardiovascular system, digestive system, hematological and lymphatic systems, endocrine system, or musculoskeletal system that are deemed clinically significant by the investigator.
- •History of organic heart disease
- •History of hypersensitivity or allergy to active ingredients.
- •Average daily smoking >5 cigarettes within 3 months prior to screening or inability to abstain during the trial.
- •Average weekly alcohol intake >14 units within 3 months prior to screening or positive alcohol breath test.
- •History of drug abuse or illicit drug use, or positive urine drug screen.
- •Participation in any other investigational drug trial within 3 months prior to screening.
- •Use of any prescription/non-prescription medication within 2 weeks prior to investigational product administration.
- •History of needle/phobia or inability to tolerate venipuncture.
- •Hemorrhoids/active perianal bleeding, chronic constipation/diarrhea or positive fecal occult blood test at screening.
- •Occupational radiation exposure;
- •Pregnancy plans during or within 1 year post-trial, or refusal to use strict contraception by subject/partner during and within 1 year post-trial.
研究组 & 干预措施
SSS17
Experimental
干预措施: [14C]SSS17 (Drug)
结局指标
主要结局
Cumulative excretion rate of radioactivity in excreta (urine, feces) and total radioactivity (urine and feces)
时间窗: up to Day 22
Cmax
时间窗: up to day22
Tmax
时间窗: up to Day22
次要结局
- AEs(up to day 22)
研究者
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