NCT05921890已完成1 期
To Evaluate the Safety and Tolerability of GS3-007a Oral Solution in a Multi-dose, Randomized, Open, Single-center Study in Healthy Chinese Adult 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
- 36
- 试验地点
- 1
- 主要终点
- TEAEs
研究概览
简要总结
To evaluate the safety and tolerability of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects.
详细描述
To evaluate the pharmacodynamic (PD) and pharmacokinetics（PK） characteristics of GS3-007a oral solution after multiple oral administration in Chinese healthy adult 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
- 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 subjects aged 18-45 years (including boundary values), male or female;
- •Body mass index: 19-26 kg/m2 (including boundary values), male weight ≥50 kg, female weight ≥45 kg;
排除标准
- •(Screening period consultation) accumulated two or more allergies to other drugs, food and environment; Or prone to rash, urticaria and other allergic symptoms; Or are known to be allergic to growth hormone-promoting peptide drugs or excipients of this preparation;
- •(screening period) have a clear history of neurological or mental disorders; Persons with incapacity or cognitive impairment;
- •ALT and AST exceed the upper limit of the normal range;
研究组 & 干预措施
GS3-007 oral liquid
Experimental
36 subjects，12 subjects in each dose group. Two dose groups were planned: 0.8 mg/kg and 1.6 mg/kg once a day for 4 weeks. According to the research progress of 1.6mg/kg QD, it was decided whether to add 0.8 mg/kg twice a day for 4 weeks.
干预措施: GS3-007 oral liquid (Drug)
结局指标
主要结局
TEAEs
时间窗: 35 Days
次要结局
未报告次要终点
研究者
研究点 (1)
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