Phase I Study to Evaluate the Safety, Tolerability, Pharmacodynamics (PD) and Pharmacokinetics (PK) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 32
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study is to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of Niclosamide (DWRX2003) following escalating doses of DWRX2003 administered as an intramuscular injection in healthy 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
- 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
- •Normal healthy human adult male and female volunteers between 18-45 years (both ages inclusive) of age.
- •Volunteers who agree to give written informed consent and are willing to participate in the study.
- •Volunteer having bodyweight minimum of 50 kg.
- •Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive).
排除标准
- •Known allergic to Niclosamide or any component of the formulation and to any other related drug.
- •History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
- •Female volunteers who are nursing mothers/lactating women or are found positive in beta hCG test.
- •History/ current use of Alcohol or drug abuse.
研究组 & 干预措施
cohort 1 (144 mg)
Arms (both) 0.1 mL/site*2 sites Hips (both) 0.2 mL/site*2 sites
干预措施: DWRX2003 (Drug)
cohort 1 (144 mg)
Arms (both) 0.1 mL/site*2 sites Hips (both) 0.2 mL/site*2 sites
干预措施: Placebo (Drug)
cohort 2 (432 mg)
Arms (both) 0.3 mL/site *2 sites Hips (both) 0.6 mL/site*2 sites
干预措施: DWRX2003 (Drug)
cohort 2 (432 mg)
Arms (both) 0.3 mL/site *2 sites Hips (both) 0.6 mL/site*2 sites
干预措施: Placebo (Drug)
cohort 3 (960 mg)
Arms (both) 0.8 mL/site*2 sites Hips (both) 1.2 mL/site*2 sites
干预措施: DWRX2003 (Drug)
cohort 3 (960 mg)
Arms (both) 0.8 mL/site*2 sites Hips (both) 1.2 mL/site*2 sites
干预措施: Placebo (Drug)
cohort 4 (1200 mg)
Arms (both) 1.0 mL/site *2 sites Hips (both) 1.5 mL/site*2 sites
干预措施: DWRX2003 (Drug)
cohort 4 (1200 mg)
Arms (both) 1.0 mL/site *2 sites Hips (both) 1.5 mL/site*2 sites
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: follow-up 48 days after dosing
AE rate, incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
次要结局
- pharmacokinetic changes of niclosamide from baseline in each dose group: Cmax(follow-up 48 days after dosing)
- pharmcodynamic analysis of niclosamide from baseline in each dose group and time point: CRP(on Day 3, 7, 10 and 14)
- pharmacokinetic changes of niclosamide from baseline in each dose group: Tmax(follow-up 48 days after dosing)