A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Ascending and Multiple-Ascending Doses of the Influenza A Virus Replication Inhibitor CC-42344
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
研究概览
简要总结
CC-42344 Phase 1 study with single-ascending dose (SAD) and multiple-ascending dose (MAD) parts.
详细描述
This study is testing the safety, tolerability, and pharmacokinetics (PK, the amount of study drug in the blood) of a new drug called CC-42344.Up to 78 healthy men or women aged between 18-55 are planned to be enrolled in this study in two parts.
Part 1 will involve a single-ascending (increasing) dose (SAD) where 32 participants (4 groups of 8) will be assigned randomly to receive a single oral dose of the study drug or placebo. The placebo will look the same as the study drug but will not contain any medicine. An additional 6 participants will receive a single oral dose of CC-42344 to help further understand the effect of food on the uptake of the drug.
Part 2: will involve a multiple-ascending dose (MAD) where 40 participants (5 groups of 8) will be randomized to receive an oral dose of study drug or placebo given once a day for 14 days, once a day for 5 days, or twice a day for 5 days. The placebo will look the same as the study drug but will not contain any medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
active and placebo capsules identical visually.
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 healthy, non-pregnant, non-lactating females
- •Body weight of at least 50 kg
- •Body mass index between ≥18.0 and ≤32.0 kg/m2
- •Good state of health (mentally and physically)
- •Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test, if required and per site policy
排除标准
- •Have received any investigational drug in a clinical research study within the previous 30 days before screening
- •Have received any vaccine within 7 days prior to randomization
- •History of any drug or alcohol abuse in the past 2 years
- •Females of childbearing potential who are pregnant or lactating or planning to become pregnant during the study
- •Clinically significant abnormal biochemistry, hematology, coagulation, or urinalysis as judged by the investigator
研究组 & 干预措施
SAD cohort 1A
first dose level with 6 active and 2 placebo healthy participants
干预措施: CC-42344 (Drug)
SAD cohort 1A
first dose level with 6 active and 2 placebo healthy participants
干预措施: Placebo (Drug)
SAD cohort 1B
second dose level with 6 active and 2 placebo healthy participants
干预措施: CC-42344 (Drug)
SAD cohort 1B
second dose level with 6 active and 2 placebo healthy participants
干预措施: Placebo (Drug)
SAD cohort 1C
third dose level with 12 active and 2 placebo healthy participants; food-effect cohort
干预措施: CC-42344 (Drug)
SAD cohort 1C
third dose level with 12 active and 2 placebo healthy participants; food-effect cohort
干预措施: Placebo (Drug)
SAD cohort 1D
fourth dose level with 6 active and 2 placebo healthy participants
干预措施: CC-42344 (Drug)
SAD cohort 1D
fourth dose level with 6 active and 2 placebo healthy participants
干预措施: Placebo (Drug)
MAD cohort 2A
first dose level with 6 active and 2 placebo healthy participants dose x 14 days
干预措施: CC-42344 (Drug)
MAD cohort 2A
first dose level with 6 active and 2 placebo healthy participants dose x 14 days
干预措施: Placebo (Drug)
MAD cohort 2B
second dose level with 6 active and 2 placebo healthy participants dose x 14 days
干预措施: CC-42344 (Drug)
MAD cohort 2B
second dose level with 6 active and 2 placebo healthy participants dose x 14 days
干预措施: Placebo (Drug)
MAD cohort 2C
third dose level with 6 active and 2 placebo healthy participants dose x 14 days
干预措施: CC-42344 (Drug)
MAD cohort 2C
third dose level with 6 active and 2 placebo healthy participants dose x 14 days
干预措施: Placebo (Drug)
MAD cohort 2D
forth dose level with 6 active and 2 placebo healthy participants dose x 5 days
干预措施: CC-42344 (Drug)
MAD cohort 2D
forth dose level with 6 active and 2 placebo healthy participants dose x 5 days
干预措施: Placebo (Drug)
MAD cohort 2E
forth dose level with 6 active and 2 placebo healthy participants dose x 5 days
干预措施: CC-42344 (Drug)
MAD cohort 2E
forth dose level with 6 active and 2 placebo healthy participants dose x 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1 SAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
时间窗: Up to 16 days
AE was defined as any new unfavorable or unintended sign, symptom, or disease or change of an existing condition, which occurs during or after treatment, whether or not considered treatment-related. A clinically significant laboratory value should be reported as an adverse event.
Part 1 SAD: Number of Participants With Clinically Significant Laboratory Abnormalities
时间窗: Up to 16 days
Number of participants with clinically significant laboratory abnormalities was reported.
Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
时间窗: Up to 16 days
Number of participants with clinically significant changes from baseline in vital signs was reported
Part 1 SAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)
时间窗: Up to 16 days
Number of participants with clinically significant changes from baseline in ECG was reported
Part 2 MAD: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
时间窗: Up to 21 days
AE was defined as any new unfavorable or unintended sign, symptom, or disease or change of an existing condition, which occurs during or after treatment, whether or not considered treatment-related. A clinically significant laboratory value should be reported as an adverse event.
Part 2 MAD: Number of Participants With Clinically Significant Laboratory Abnormalities
时间窗: Up to 21 days
Number of participants with clinically significant laboratory abnormalities was reported
Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
时间窗: Up to 21 days
Number of participants with clinically significant changes from baseline in vital signs was reported
Part 2 MAD: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)
时间窗: Up to 14 days
Number of participants with clinically significant changes from baseline in ECGs was reported.
次要结局
- Part 1 SAD: Maximum Plasma Concentration (Cmax) of CC-42344(Day 1: -0.5, 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) of CC-42344(Day 1: -0.5, 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 From Time 0 to t (AUC0-t) of CC-42344(Day 1: -0.5, 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 (λz) of CC-42344(Day 1: -0.5, 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) of CC-42344(Day 1: -0.5, 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 From Time 0 to Infinity (AUC0-inf) of CC-42344(Day 1: -0.5, 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: Maximum Plasma Concentration (Cmax) of CC-42344 - Fasted vs Fed(Day 1 and Day 9: -0.5, 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) of CC-42344 - Fasted vs Fed(Day 1 and Day 9: -0.5, 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 From Time 0 to t (AUC0-t) of CC-42344 - Fasted vs Fed(Day 1 and Day 9: -0.5, 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 From Time 0 to Infinity (AUC0-inf) of CC-42344 - Fasted vs Fed(Day 1 and Day 9: -0.5, 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 CC-42344(Day 1: Pre-dose through 24 h post-dose, Day 5: Pre-dose through 96 h post-dose, and Day 14: Pre-dose through 96 h post-dose)
- Part 2 MAD: Time of Maximum Plasma Concentration (Tmax) of CC-42344(Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, and 24 h post-dose Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4,)
- Part 2 MAD: Elimination Rate Constant (λz) of CC-42344(Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose)
- Part 2 MAD: Terminal Elimination Half-life (t1/2) of CC-42344(Day 5: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose Day 14: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, and 96 h post-dose)