A Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of APB-R3 following IV administration of single ascending dose in healthy participants.
研究概览
简要总结
This will be a single centre, Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants.
详细描述
Primary objective of this study will be to evaluate the safety and tolerability of APB-R3 following intravenous (IV) administration of single ascending dose in healthy participants.
The study will consist of 5 planned cohorts (1 cohort per dose level) for a total of up to 31 participants. Cohorts 1 and 2 will include 5 participants each (3 participants receiving the active and 2 participants receiving the placebo). Cohort 3 to Cohort 5 will include 7 participants each (5 participants receiving the active and 2 participants receiving the placebo).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will be double-blinded. The participants and the clinical personnel involved in the collection, monitoring, revision, or evaluation of AEs, or personnel who could have an impact on the outcome of the study will be blinded with respect to the participant's treatment assignment (APB-R3 or placebo).
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, non-smoker, 18 to 60 years of age (both inclusive),
- •Healthy as defined by:
- •the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration in the opinion of the investigator.
- •the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease in the opinion of the investigator.
排除标准
- •Abnormal finding at physical examination
- •Evidence of clinical significant hepatic or renal impairment
- •Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, or positive test results for COVID-19, or QuantiFERON®-TB test at screening.
- •Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
研究组 & 干预措施
SAD cohort
SAD cohorts 1-5. Randomised participants in each cohort will receive a single IV dose of APB-R3.
干预措施: APB-R3 (Drug)
Placebo
SAD cohorts 1-5. 2 randomised participants of each cohort will receive a placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of APB-R3 following IV administration of single ascending dose in healthy participants.
时间窗: Upto 92 days
Number of participants with serious and other non-serious adverse events.
次要结局
- PK (Pharmacokinetic) assessment of APB-R3(Upto 92 days)
- Immunogenicity assessment of APB-R3(Upto 92 days)
- PD (Pharmacodynamics) effect assessment of APB-R3(Upto 92 days)