NCT07081503招募中1 期
A Phase 1, Randomized, Blinded, Placebo-Controlled Study to Assess ADX-626 in Healthy Participants
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Safety of ADX-626 in Healthy Participants
研究概览
简要总结
This first-in-human study will evaluate the safety and tolerability of ADX-626 in healthy participants. The study will also look at how ADX-626 interacts with the human body (the pharmacokinetics and pharmacodynamics of ADX-626).
详细描述
A Phase 1, first-in-human study to assess the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-626 compared with placebo in healthy participants.
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
- Double (Participant, 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
- •Age 18 to 45 years at the time of informed consent
- •Males or women of non-childbearing potential (WONCBP)
- •Willing to comply with all study requirements while participating
- •Suitable venous access for blood sampling.
- •Body weight ≥ 50 kg and a body mass index (BMI) ≤25 kg/m2
- •Normal laboratory results including liver enzymes, hemoglobin, platelet count, and coagulation parameters
- •Willing to use acceptable contraception methods if applicable
排除标准
- •Significant medical condition such as hypertension, diabetes, cardiovascular disease, or cancer
- •History of bleeding or coagulation disorders, prior instances of major bleeding, or a family history of bleeding disorders.
- •Current infection
- •Participation in an interventional drug study within the last 90 days
研究组 & 干预措施
ADX-626
Experimental
干预措施: ADX-626 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety of ADX-626 in Healthy Participants
时间窗: Day 1 to Day 365
Incidence, relationship and severity of adverse events and serious adverse events
次要结局
- Pharmacokinetics (PK) of ADX-626 - Exposure(Day 1 to Day 29)
- Pharmacodynamics (PD) of ADX-626 - Blood Clotting Time(Day 1 to Day 365)
- Pharmacokinetics (PK) of ADX-626 - Maximum Concentration(Day 1 to Day 29)
- Pharmacodynamics (PD) of ADX-626 - Factor XI(Day 1 to Day 365)
- Pharmacokinetics (PK) of ADX-626 - Time to Maximum Concentration(Day 1 to Day 29)
研究者
研究点 (1)
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