A Single Center, Phase I, Double-Blind, Placebo-Controlled Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters - Maximum Concentration (Cmax)
研究概览
简要总结
Single center, randomized, double-blinded, placebo-controlled, single ascending-dose study for the evaluation of the safety, tolerability, and PK following single oral doses of INV-101.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Fully blinded
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male or female
- •Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively; and body weight ≥60 kg
- •Non- or ex-smoker
- •Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator
排除标准
- •Female who is pregnant or lactating
- •Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
- •History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- •Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment (maximum QTc of 450 for males and 470 for females)
研究组 & 干预措施
Cohort 3
Subjects will be randomized to receive either placebo or 160 mg INV-101
干预措施: Placebo (Drug)
Cohort 4
Subjects will be randomized to receive either placebo or 320 mg INV-101
干预措施: INV-101 (Drug)
Cohort 1
Subjects will be randomized to receive either placebo or 20 mg INV-101
干预措施: INV-101 (Drug)
Cohort 1
Subjects will be randomized to receive either placebo or 20 mg INV-101
干预措施: Placebo (Drug)
Cohort 2
Subjects will be randomized to receive either placebo or 80 mg INV-101
干预措施: INV-101 (Drug)
Cohort 2
Subjects will be randomized to receive either placebo or 80 mg INV-101
干预措施: Placebo (Drug)
Cohort 3
Subjects will be randomized to receive either placebo or 160 mg INV-101
干预措施: INV-101 (Drug)
Cohort 4
Subjects will be randomized to receive either placebo or 320 mg INV-101
干预措施: Placebo (Drug)
Cohort 5
Subjects will be randomized to receive either placebo or 500 mg INV-101
干预措施: INV-101 (Drug)
Cohort 5
Subjects will be randomized to receive either placebo or 500 mg INV-101
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetic parameters - Maximum Concentration (Cmax)
时间窗: 72 hours
Cmax following single dose
Pharmacokinetic parameters - AUC
时间窗: 72 hours
AUC following single dose
Pharmacokinetic parameters - Half-live
时间窗: 72 hours
Half-live following single dose
次要结局
- Adverse events(72 hours)