NCT07616791已完成1 期
A Phase I, Single and Multiple Ascending Dose Escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Subjects
Innatus Therapeutics (Shanghai) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年9月4日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
研究概览
简要总结
A Phase Ⅰ, Single and Multiple Ascending Dose escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Voluteers.
Primary Objectives:
● To assess the safety and tolerability of single and multiple oral dose of INT-210 capsules in healthy adult voluteers,
Secondary Objectives:
- To assess the pharmacokinetic(PK) profile of single and multiple oral doses of INT-210 capsules in healthy adult voluteers;
- To assess the safety and tolerability of INT-210 capsulese administered under fasting and fed(high-fat-meal) conditions in healthy adult voluteers;
- To assess the effect of food on the PK profile of a single oral dose of INT-210 capsules in healthy adult voluteers;
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female healthy voluteers
- •Aged 18-45 years(inclusive),
- •In good general health with no evidence of active or chronic disease; and who agree to comply with the prescribed contraceptive requirement during the trial and for 3 months after the last dose.
排除标准
- •Female who are pregnant or breastfeeding; or planing pregnancy, female of chidbearing potential not using adequate contraception.
- •Pre-existing significant medical conditions(cardiac, hepatic, renal, gastrointestina, etc), abnormal lab results, active infection, or history of special conditions like long QT syndrome or hypocalcemia.
- •Positive screening for HIV, Hepatitis B/C or syphilis;
- •Recent subject in another clinical trial;
- •Recent major surgery, or significant blood loss.
研究者
研究点 (1)
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