NCT07460284尚未招募1 期
A Mass Balance Study of 14C-RAY1225 Injection in Healthy Chinese Participants
Guangdong Raynovent Biotech Co., Ltd1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2026年3月15日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Total radioactivity recovery and cumulative recovery in urine and feces in each time period;
研究概览
简要总结
This is an open-label, single-center, single-dose study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who sign the informed consent form, fully understand the content, process, and possible adverse reactions of the study, and are able to complete the study as required by the study protocol;
- •Healthy adult males aged 18-55 years (inclusive, based on the time of signing the ICF);
- •Weight ≥ 50 kg, and body mass index (BMI) = weight (kg)/height2 (m 2) between 20.0-35.0 kg/m2 (inclusive);
- •Participants (including partners) who agree to voluntarily use effective contraception from screening until 6 months after the investigational drug administration and have no sperm donation plan. For specific contraceptive measures
排除标准
- •Subjects with trauma, surgical scar, or skin lesions at the proposed administration site (abdomen) who are not suitable for subcutaneous injection as assessed by the investigator;
- •History of hypoglycemic episodes within 12 months prior to screening;
- •Major surgery or serious infection within 12 weeks prior to screening;
- •Acute disease from the signing of the ICF to the administration of the investigational drug;
- •Smoking more than 5 cigarettes per day within 12 weeks prior to screening, or unable to abstain from smoking within 7 days prior to admission and during the study;
- •Participants who are not otherwise eligible to participate in this study.
研究组 & 干预措施
RAY1225
Experimental
干预措施: 14C-RAY1225 (Drug)
结局指标
主要结局
Total radioactivity recovery and cumulative recovery in urine and feces in each time period;
时间窗: DAY1~DAY60
To quantitatively analyze the total radioactivity in the excretions of healthy participants after subcutaneous injection of 14C-RAY1225, and to obtain the primary radioactivity recovery data and primary excretion pathways in humans;
Radioactivity of each metabolite in urine and feces as a percentage of the total administered dose and the circulating metabolites in plasma as a percentage of the total exposure AUC (%AUC);
时间窗: DAY1~DAY60
次要结局
- Occurrence of adverse events/significant adverse events/serious adverse events(DAY1~DAY60)
研究者
研究点 (1)
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