NCT04541485终止1 期
Phase I Study to Evaluate the Safety, Tolerability, and Pharmacodynamics (PD) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in COVID-19 Patients
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2020年12月4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
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 65 years of age, inclusive at time of signing the ICF.
- •Subjects with low to moderate risk defined as NEWS COVID-19 infection as confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay 72 hours prior to clinical trial enrollment.
排除标准
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note patients with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
- •Significant history, clinical manifestation of any medical disorder or any comorbid conditions which in the opinion of the investigator may interfere with the study
研究组 & 干预措施
Experimental: Cohort 1 (96 mg)
Experimental
24 mg/0.1 mL x 4 sites
干预措施: DWRX2003 (Drug)
Experimental: Cohort 1 (96 mg)
Experimental
24 mg/0.1 mL x 4 sites
干预措施: Placebo (Drug)
Experimental: Cohort 2 (288 mg)
Experimental
72 mg/0.3 mL x 4 sites
干预措施: DWRX2003 (Drug)
Experimental: Cohort 2 (288 mg)
Experimental
72 mg/0.3 mL x 4 sites
干预措施: Placebo (Drug)
Experimental: Cohort 3 (480 mg)
Experimental
120 mg/0.5 mL x 4 sites
干预措施: DWRX2003 (Drug)
Experimental: Cohort 3 (480 mg)
Experimental
120 mg/0.5 mL x 4 sites
干预措施: Placebo (Drug)
Experimental: Cohort 4 (672 mg)
Experimental
168 mg/0.7 mL x 4 sites
干预措施: DWRX2003 (Drug)
Experimental: Cohort 4 (672 mg)
Experimental
168 mg/0.7 mL x 4 sites
干预措施: Placebo (Drug)
Experimental: Cohort 5 (960 mg)
Experimental
240 mg/1.0 mL x 4 sites
干预措施: DWRX2003 (Drug)
Experimental: Cohort 5 (960 mg)
Experimental
240 mg/1.0 mL x 4 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 42 days after dosing
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
次要结局
- Rate of SARS-CoV-2 eradication by Nasopharyngeal specimen(at Day 3, 7, 10 and 14)
- Time to SARS-CoV-2 eradication (days) by Nasopharyngeal specimen(follow-up 42 days after dosing)
研究者
研究点 (1)
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