NCT04773977已完成1 期
Clinical Study to Evaluate the Pharmacokinetics and Safety of IBI362 Lyophilized Powder and IBI362 Liquid Formulation in Healthy Chinese Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
研究概览
简要总结
This is a study to evaluate the pharmacokinetic characteristics and safety of IBI362 lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects.
详细描述
Pharmacokinetic；Safety
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •20 years old≤ Healthy males≤45 years old
- •19 kilograms per meter squared (kg/m²)≤Body Mass Index≤26 kg/m²
- •Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
排除标准
- •Subjects who have previously completed or discontinued from this study, or who have used IBI
- •Abnormal vital signs and physical examination during the screening period;
- •Having cardiovascular, respiratory, liver, kidney, digestive, endocrine, hematologic, neurological, or muscle degenerative diseases can significantly affect drug absorption, metabolism, or elimination, or participation in the study increases risk or interferes with data interpretation.
- •Have a previous or current mental illness.
- •A family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type
- •There are other factors judged by the investigators that are not suitable for inclusion in this study.
研究组 & 干预措施
IBI362 liquid formulation
Experimental
Participants received single subcutaneous injection of IBI362 liquid formulation
干预措施: IBI362 liquid formulation (Drug)
IBI362 lyophilized powder
Experimental
Participants received single subcutaneous injection of IBI362 lyophilized powder
干预措施: IBI362 lyophilized powder (Drug)
结局指标
主要结局
Evaluate the PK parameters of IBI362 in healthy Chinese male subjects
时间窗: From the first dose of study drug until 8 weeks
Area under the plasma concentration versus time curve (AUC)
次要结局
- Number of Participants With Adverse Events(From the first dose of study drug until 8 weeks)
研究者
研究点 (1)
Loading locations...
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