NCT04592835Unknown1 期
A Double-blind, Randomized, Placebo-controlled, Single-ascending Dose Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Following Intramuscular Administration in Healthy Volunteers
Daewoong Pharmaceutical Co. LTD.0 个研究点目标入组 24 人开始时间: 2020年10月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 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, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females, between 18 and 65 years of age, inclusive, at time of signing the Informed Consent Form (ICF).
- •Body mass index between 18.0 lesser than or equal to Body Mass Index (BMI) lesser than or equal to 32 at Screening, with a minimum weight of 50 kg (inclusive).
- •Willing to sign ICF on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any Screening procedure being undertaken
排除标准
- •Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note participants with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)
研究组 & 干预措施
Cohort 1 (288mg)
Experimental
72 mg/0.3 mL x 4 injection sites
干预措施: DWRX2003 (Drug)
Cohort 2 (576 mg)
Experimental
144 mg/0.6 mL x 4 injection sites
干预措施: DWRX2003 (Drug)
Cohort 3 (960 mg)
Experimental
216 mg/1.0 mL x 4 injection sites
干预措施: DWRX2003 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: follow-up 35 days after dosing
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
次要结局
- To assess PK parameters of niclosamide injectable (DWRX2003) through tmax(at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28)
- To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-∞(at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28)
- To assess PK parameters of niclosamide injectable (DWRX2003) through t1/2(at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28)
- To assess PK parameters of niclosamide injectable (DWRX2003) through Cmax(at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28)
- To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-last(at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28)
研究者
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