A Double-Blind, Randomized, Placebo-Controlled, Single- And-Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN01941 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Number of participants with ECG abnormalities
研究概览
简要总结
This is a Phase 1, double-blind, randomized, placebo-controlled, single-dose and multiple-dose study of CRN01941 in up to 119 healthy male and female subjects. This single-center study will be conducted in 3 parts: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-ascending dose phase (up to 5 cohorts, 9 subjects/cohort), and single dose phase in elderly subjects (1 cohort, 10 subjects).
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
Double-blind study
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects 18 to 55 years of age, inclusive, at time of screening (Parts 1 and 2 only).
- •Males and females subjects 65 to 85 years of age at screening (Part 3 only).
- •Females must be non-pregnant and non-lactating, postmenopausal by history and confirmed by follicle stimulating hormone (FSH) >30 U/L at Screening, or surgically sterile.
- •Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential.
- •Body mass index (BMI) of 18 to 32 kg/m2, inclusive at Screening.
- •Willing to provide signed informed consent.
排除标准
- •Any uncontrolled or active major systemic disease which makes study participation unsafe or could interfere with evaluation of the endpoints of the study.
- •History or presence of malignancy within the past 5 years, not including treated basal cell carcinomas and in situ cervical neoplasia.
- •Use of any investigational drug within the past 60 days.
- •Have a medically significant abnormality observed during screening or admission.
- •Use of any prior medication without approval of the investigator within 14 days prior to admission.
- •Subjects with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infections. Subjects with previous hepatitis C infection that is now cured may be eligible.
- •History of or current alcohol or substance abuse in the past 12 months
- •Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study.
研究组 & 干预措施
Elderly Cohort (Part 3)
干预措施: Placebo Oral Capsule (Drug)
Single Ascending Dose (Part 1)
干预措施: CRN01941 Oral Solution (Drug)
Single Ascending Dose (Part 1)
干预措施: CRN01941 Oral Capsule (Drug)
Single Ascending Dose (Part 1)
干预措施: Placebo Oral Solution (Drug)
Single Ascending Dose (Part 1)
干预措施: Placebo Oral Capsule (Drug)
Multiple Ascending Dose (Part 2)
干预措施: CRN01941 Oral Solution (Drug)
Multiple Ascending Dose (Part 2)
干预措施: CRN01941 Oral Capsule (Drug)
Multiple Ascending Dose (Part 2)
干预措施: Placebo Oral Solution (Drug)
Multiple Ascending Dose (Part 2)
干预措施: Placebo Oral Capsule (Drug)
Elderly Cohort (Part 3)
干预措施: CRN01941 Oral Solution (Drug)
Elderly Cohort (Part 3)
干预措施: CRN01941 Oral Capsule (Drug)
Elderly Cohort (Part 3)
干预措施: Placebo Oral Solution (Drug)
结局指标
主要结局
Number of participants with ECG abnormalities
时间窗: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with treatment emergent adverse events by severity
时间窗: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with serious adverse events (SAEs)
时间窗: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with clinical laboratory abnormalities
时间窗: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with clinically significant changes in vital signs
时间窗: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
次要结局
- Pharmacokinetics (AUC)(Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8)
- Pharmacokinetics (Cmax)(Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8)
- Pharmacokinetics (Tmax)(Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8)
- Pharmacokinetics (T1/2)(Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8)