NCT06640920已完成1 期
A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants
Uniquity One (UNI)1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年4月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At the time of initial screening, in general good health (age 18 to 65 years);
排除标准
- •Pregnancy or breastfeeding during the study.
- •Chronic infection - Treatment with prohibited medications.
- •Treatment with prohibited medications
研究组 & 干预措施
Cohort A
Experimental
NSI-8226
干预措施: Cohort A (Biological)
Cohort B
Experimental
NSI-8226
干预措施: Cohort B (Biological)
Cohort C
Experimental
NSI-8226
干预措施: Cohort C (Biological)
Cohort D
Experimental
NSI-8226
干预措施: Cohort D (Biological)
结局指标
主要结局
Safety and tolerability
时间窗: 140 days
To evaluate the incidence of treatment emergent adverse events of NSI-8826 in healthy participants according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0
次要结局
- Absolute bioavailability(140 days)
- Concentration of immunogenicity(140 days)
- Parameters in healthy participants(140 days)
研究者
研究点 (1)
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