NCT05019950已完成1 期
A Randomized, Placebo-Controlled, Double-Blind, Single-Center Study to Evaluate Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers
NImmune Biopharma1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2021年10月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The primary objective of this study is to assess the safety and tolerability of single and 7-day repeat oral doses NIM-1324 in healthy adult volunteers.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects;
- •Adult males and females, 18 to 64 years of age (inclusive) at screening;
- •Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
排除标准
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;
- •Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications;
- •COVID-19: Testing positive for COVID-19, a current symptomatic infection within 20 days, or an asymptomatic infection within 6 weeks.
研究组 & 干预措施
NIM-1324
Experimental
Once daily oral tablet
干预措施: NIM-1324 (Drug)
Placebo
Placebo Comparator
Once daily oral tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 1 to 14 days
次要结局
- PK(24 hours)
研究者
研究点 (1)
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