A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Ascending and Multiple-Ascending Doses of Oral CDI-988 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Laboratory abnormalities
研究概览
简要总结
The goal of this clinical trial is to learn about the safety and pharmacokinetics (PK, the amount of drug in the blood) of a new drug called CDI-988 in healthy volunteers.
The main questions it aims to answer are:
- Are there any side effects of the drug?
- What is the amount of drug that reaches the bloodstream? Participants will be assigned by chance to take either CDI-988 or placebo by mouth and have physical exams, electrocardiograms (ECGs), vital signs, and blood tests to look for any side effects.
详细描述
CDI-988 is a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) 3-chymotrypsin-like (3CL) protease inhibitor for oral administration. This study is being conducted in 2 parts to examine the safety, tolerability, and PK of CDI-988 in healthy participants. Part 1 will entail escalating single doses in sequential cohorts and Part 2 will enroll escalating multiple-dose cohorts. Participants will be monitored for adverse events, vital signs, laboratory values, and electrocardiograms (ECGs).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or non-pregnant, non-lactating females
- •Body weight of at least 45 kg.
- •Body mass index ≥18.0 and ≤32.0 kg/m2
- •Good state of mental and physical health
- •Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test
排除标准
- •Received an investigational drug within 30 days
- •Received a coronavirus disease 2019 (COVID-19) vaccine within 7 days
- •Drug or alcohol abuse in the past 12 months
- •Clinically significant abnormal biochemistry, hematology, coagulation, urinalysis test results
- •Clinically significant abnormal ECG or vital signs
研究组 & 干预措施
SAD Cohort 1C
third single-dose level; food-effect cohort
干预措施: CDI-988 (Drug)
SAD Cohort 1C
third single-dose level; food-effect cohort
干预措施: Placebo (Drug)
SAD Cohort 1D
fourth single-dose level
干预措施: Placebo (Drug)
MAD Cohort 2A
first multiple-dose level
干预措施: CDI-988 (Drug)
MAD Cohort 2A
first multiple-dose level
干预措施: Placebo (Drug)
MAD Cohort 2C
third multiple-dose level
干预措施: CDI-988 (Drug)
SAD Cohort 1F
sixth dose level
干预措施: Placebo (Drug)
MAD Cohort 2F
6th multiple dose level
干预措施: CDI-988 (Drug)
MAD Cohort 2F
6th multiple dose level
干预措施: Placebo (Drug)
SAD Cohort 1B
second single-dose level
干预措施: CDI-988 (Drug)
SAD Cohort 1B
second single-dose level
干预措施: Placebo (Drug)
SAD Cohort 1A
first single-dose level
干预措施: CDI-988 (Drug)
MAD Cohort 2B
second multiple-dose level
干预措施: Placebo (Drug)
MAD Cohort 2C
third multiple-dose level
干预措施: Placebo (Drug)
SAD Cohort 1E
fifth dose level; food effect cohort
干预措施: Placebo (Drug)
MAD Cohort 2D
4th multiple dose level
干预措施: Placebo (Drug)
MAD Cohort 2E
5th multiple dose level
干预措施: Placebo (Drug)
SAD Cohort 1D
fourth single-dose level
干预措施: CDI-988 (Drug)
MAD Cohort 2B
second multiple-dose level
干预措施: CDI-988 (Drug)
SAD Cohort 1E
fifth dose level; food effect cohort
干预措施: CDI-988 (Drug)
MAD Cohort 2D
4th multiple dose level
干预措施: CDI-988 (Drug)
SAD Cohort 1F
sixth dose level
干预措施: CDI-988 (Drug)
MAD Cohort 2E
5th multiple dose level
干预措施: CDI-988 (Drug)
SAD Cohort 1A
first single-dose level
干预措施: Placebo (Drug)
结局指标
主要结局
Laboratory abnormalities
时间窗: Day 1 to 7 days after last dose
number of participants with clinically significant laboratory abnormalities
Vital signs
时间窗: Day 1 to 7 days after last dose
number of participants with clinically significant changes from baseline in vital signs
Adverse events
时间窗: Day 1 to 7 days after last dose
number of participants with treatment-emergent adverse events
ECGs
时间窗: Day 1 to 7 days after last dose
number of participants with clinically significant changes from baseline in ECGs
Adverse Events
时间窗: Up to 17 days
number of participants with treatment-emergent adverse events
Laboratory Abnormalities
时间窗: Up to 17 days
number of participants with clinically significant laboratory abnormalities
Vital Signs
时间窗: Day 1 to 7 days after last dose
number of participants with clinically significant changes from baseline in vital signs
次要结局
- Area under the plasma concentration-time curve (AUC)(Day 1 to 3 days after last dose)
- Terminal elimination half-life (t1/2)(Day 1 to 3 days after last dose)
- Maximum plasma concentration (Cmax)(Day 1 to 3 days after last dose)
- Time of maximum plasma concentration (Tmax)(Day 1 to 7 days after last dose)
- Elimination rate constant (lambda Z)(Day 1 to 3 days after last dose)
- Part 1 SAD Maximum Plasma Concentration (Cmax)(predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose)
- Part 1 SAD Time of Maximum Plasma Concentration (Tmax)(predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose)
- Part 1 SAD Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to t (AUC0-t) of CDI-988(pre dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose)
- Part 1 SAD Elimination Rate Constant (Lambda Z)(predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose)
- Part 1 SAD Terminal Elimination Half-life (t1/2)(predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 h post dose)
- Part 2 MAD: Maximum Plasma Concentration (Cmax) of CDI-988(Day 1, Day 5 and Day 10: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36 and 48h post-dose)
- Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CDI-988(Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36, and 48 h)
- Part 2 MAD: Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of CDI-988(Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36, and 48 h)
- Part 2 MAD: Elimination Rate Constant (λz) of CDI-988(Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36 and 48 h)
- Part 2 MAD: Terminal Elimination Half-life (t1/2) of CDI-988(Day 1, 5 or 10: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4. 6, 8, 12, 24, 36 and 48 h)