A Phase 1, Randomized, Double-blind, Placebo-controlled, 2-Part Study to Assess Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of INS1033 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 116
- 主要终点
- Number of Participants Who Experienced at-Least One Adverse Event (AE) by Dose Level
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of INS1033 in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis.
- •All values for hematology, coagulation and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator. Clinical laboratory tests may be repeated once.
排除标准
- •Use of any investigational drug or device within 30 days of the first dose of INS1033, or within 5 half-lives, whichever is longer.
- •Any disease e.g. which, in the opinion of the Investigator, poses an unacceptable risk to the participants.
- •Clinically significant history of any drug sensitivity, drug allergy, or food allergy, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). Confirmatory circumstances would include treatment with epinephrine or in Emergency Department.
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Part 1: Single Ascending Dose (SAD)
Participants will receive single ascending dose (SAD) of INS1033 or a matching placebo orally under fasted conditions on Day 1.
干预措施: INS1033 (Drug)
Part 1: Single Ascending Dose (SAD)
Participants will receive single ascending dose (SAD) of INS1033 or a matching placebo orally under fasted conditions on Day 1.
干预措施: Placebo (Drug)
Part 2: Multiple Ascending Dose (MAD)
Participants will receive multiple ascending dose (MAD) of INS1033 or a matching placebo orally under fasted conditions for up to 14 days.
干预措施: INS1033 (Drug)
Part 2: Multiple Ascending Dose (MAD)
Participants will receive multiple ascending dose (MAD) of INS1033 or a matching placebo orally under fasted conditions for up to 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experienced at-Least One Adverse Event (AE) by Dose Level
时间窗: Part 1: Up to Day 7; Part 2: Up to Day 21
次要结局
- Plasma Concentration of INS1033(Pre-dose and post-dose at multiple timepoints (Part 1: Up to Day 7; Part 2: Up to Day 21))