NCT06530966已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-332 in Healthy Subjects
InnoCare Pharma Inc.2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年7月23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
- 24
- 试验地点
- 2
- 主要终点
- Number of Participants With Clinically Significant Change in Vital Signs
研究概览
简要总结
A multiple ascending dose phase I study of ICP-332 in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Voluntarily sign the informed consent form
- •Body mass index (BMI) of ≥ 18.5 kg/m2 and < 30 kg/m2
- •Male or infertile female subjects who are between 18-55 years old (inclusive)
排除标准
- •Significant current or past acute or chronic disease or condition.
- •A history of tuberculosis or current active/latent infection.
- •With a history of drug or food allergy, or allergy to any of the composition components of the study drug, or allergic disease.
- •Subjects with clinically significant abnormalities in the screening examinations.
研究组 & 干预措施
ICP-332
Experimental
干预措施: ICP-332 Tablets (Drug)
Placebo
Placebo Comparator
干预措施: ICP-332 Placebo Tablets (Drug)
结局指标
主要结局
Number of Participants With Clinically Significant Change in Vital Signs
时间窗: Up to Day 28
Number of Participants With Clinically Significant Change in Physical Examination
时间窗: Up to Day 28
Number of Participants With Clinically Significant Change in Clinical Laboratory Values
时间窗: Up to Day 28
Number of participants with Adverse Events (AEs)
时间窗: Up to Day 28
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)
时间窗: Up to Day 28
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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