NCT05596045撤回1 期
A Phase Ib, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 Tablets in Mild or Moderate COVID-19 Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses
研究概览
简要总结
This is a phase Ib, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, efficacy and pharmacokinetics of ASC10 tablets in mild or moderate COVID-19 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥18 years at screening;
- •Those females who do not have plans for pregnancy within six months and are willing to take effective contraceptive measures from the first dose of the study drug to 3 months after the last dose;
- •If male, agree to use adequate contraception throughout the study and for at least 3 months after the last dose of study drug;
- •Has a documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤5 days prior to randomization.
排除标准
- •Females who are pregnant, planning to become pregnant, or breastfeeding;
- •Has at least one characteristic or underlying medical condition associated with an increased risk of developing severe or critical illness from COVID-19;
- •Has hypersensitivity or other contraindication to any of the components of the study interventions;
- •Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.
研究组 & 干预措施
ASC10
Experimental
Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days
干预措施: ASC10 (Drug)
Placebo
Placebo Comparator
Participants will be randomized to receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses
时间窗: From Day 0 to Study Completion, up to 32 days
PK parameters for ASC10, GLC01-700 (molnupiravir) and ASC10-A in plasma as AUC0-12h
时间窗: From Day 1 to Day 6
次要结局
- Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms(From Day 1 to Study Completion, up to 32 days)
研究者
研究点 (2)
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