NCT07662057招募中1 期
A Double-Blind, Randomized, Placebo-Controlled, Combined Single Ascending Dose and Multiple Ascending Dose First-In-Human Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AB102 in Healthy Participants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is assess the safety and tolerability of AB102 and characterize the pharmacokinetics (PK) profile of AB102 after single and multiple ascending oral dose(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Understands the study procedures in the Informed Consent Form and is willing and able to comply with the protocol.
- •BMI: 19.0 to 30.0 kg/m2, inclusive, at screening.
- •All prescribed medication must have been stopped at least 30 days prior to admission to the clinical site. An exception is made for hormonal contraceptives that may be used throughout the study.
- •Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, vital signs, and complete neurological examination, as judged by the Investigator.
- •Participants must follow protocol-specified contraception guidance.
排除标准
- •Have a history of relevant atopy, drug hypersensitivity and/or food allergies.
- •Using tobacco products within 3 months prior to the screening.
- •Have a significant infection or known inflammatory process on screening or admission.
- •Have received any vaccination within 14 days of admission date for non-live vaccines or 28 days of admission date for live attenuated vaccines.
- •History of alcohol abuse or drug addiction in the last 2 years (including soft drugs like cannabis products).
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
MAD Part
Placebo Comparator
Escalating multiple oral doses of AB102 will be given to participants
干预措施: AB102 (Drug)
SAD Part
Experimental
Escalating single oral doses of AB102 will be given to participants
干预措施: AB102 (Drug)
SAD Part Placebo
Experimental
Escalating single oral doses of placebo will be given to participants
干预措施: Placebo (Other)
MAD Part Placebo
Placebo Comparator
Escalating multiple oral doses of placebo will be given to participants
干预措施: Placebo (Other)
研究者
研究点 (1)
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