A Phase 1a Study of IMR-687 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Number of participants with treatment emergent adverse events and serious adverse events
研究概览
简要总结
The purpose of this Phase 1a, first in human, randomized, double-blind, placebo-controlled study is to evaluate the safety, tolerability, PK and PD profile of the orally administered IMR-687 in healthy adult 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)
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
- •Be healthy as judged by the Investigator on the basis of pre-study tests performed at Screening, with healthy body mass index (BMI), healthy body weight, and laboratory results within normal laboratory reference range or determined not to be clinically significant by the Investigator; and be free from drugs of abuse.
排除标准
- •Females who are pregnant, trying to become pregnant, or breastfeeding; and males with female partners who are trying to conceive.
- •Asthmatics or other individuals who use or may use albuterol rescue inhalers or nebulizers.
- •A significant history of cardiovascular disease.
- •On ECG, a QTcF >450 ms or the presence of clinically significant abnormalities as determined by the Investigator.
- •Elevated blood pressure.
- •Use within 30 days prior to Day 1 of any inhibitors or substrates of targets of IMR-687.
研究组 & 干预措施
Cohort 3
4 Subjects will receive a single mid-low dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
干预措施: Placebo Oral Capsule (Drug)
Cohort 4
4 Subjects will receive a single mid dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
干预措施: IMR-687 (Drug)
Cohort 1
4 Subjects will receive a single low dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
干预措施: IMR-687 (Drug)
Cohort 1
4 Subjects will receive a single low dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
干预措施: Placebo Oral Capsule (Drug)
Cohort 2
4 Subjects will receive a single low-mid dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
干预措施: IMR-687 (Drug)
Cohort 2
4 Subjects will receive a single low-mid dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
干预措施: Placebo Oral Capsule (Drug)
Cohort 3
4 Subjects will receive a single mid-low dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
干预措施: IMR-687 (Drug)
Cohort 4
4 Subjects will receive a single mid dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
干预措施: Placebo Oral Capsule (Drug)
Cohort 5
4 Subjects will receive a single mid-high dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
干预措施: IMR-687 (Drug)
Cohort 5
4 Subjects will receive a single mid-high dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
干预措施: Placebo Oral Capsule (Drug)
Cohort 6
4 Subjects will receive a single high dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
干预措施: IMR-687 (Drug)
Cohort 6
4 Subjects will receive a single high dose of IMR-687, administered orally following an overnight fast.
2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
Number of participants with treatment emergent adverse events and serious adverse events
时间窗: 5 Days
Number of participants with clinically significant changes from baseline in vital signs
时间窗: Baseline to Day 5
Vital signs include blood pressure, heart rate, pulse rate, and oral temperature
Number of participants with clinically significant changes from baseline in 12-lead ECG parameters
时间窗: Baseline to Day 2
Number of participants with clinically significant changes from baseline in physical examination
时间窗: Baseline to Day 5
Number of participants with clinically significant changes from baseline in hematology, chemistry, coagulation and urinalysis laboratory values
时间窗: Baseline to Day 5
Use of concomitant medications and therapies, medication type and frequency
时间窗: 5 Days
次要结局
- The change from baseline in QTcF interval.(2 Days)
- Pharmacokinetics (PK) of IMR-687(Day 1 prior to administration of drug and 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post dose)