NCT05001022终止1 期
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study of Subcutaneously Administered ALG-020572 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Doses in Healthy Volunteers (Part 1) and Multiple Doses in Subjects With Chronic Hepatitis B (Part 2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
A Randomized Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ALG-020572
Experimental
Subcutaneous injections of ALG-020572 in HV or CHB subjects, up to 7 injections over the course of up to 29 days
干预措施: ALG-020572 (Drug)
Placebo
Placebo Comparator
Subcutaneous injections of placebo in HV or CHB subjects, up to 7 injections over the course of up to 29 days
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: up to 120 days for Part 2
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
次要结局
- Half-time [t1/2](Predose (0 hours) up to 45 Days (1080 hours))
- Area under the concentration time curve [AUC](Predose (0 hours) up to 45 Days (1080 hours))
- Time to maximum plasma concentration [Tmax](Predose (0 hours) up to 45 Days (1080 hours))
- Maximum Plasma Concentration [Cmax](Predose (0 hours) up to 45 Days (1080 hours))
- Minimum Plasma Concentration [Cmin](Predose (0 hours) up to 45 Days (1080 hours))
- Change in HBsAg (reduction) from baseline through Day 120 in Multiple Dose HBV Infected Patients(Screening, Day 1, 2, 4, 8, 11, 15, 22, 29, 36, 45, 60, 90, 120)
研究者
研究点 (3)
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