NCT03331900已完成1 期
A Phase 1 Single Ascending Dose Study of COR388 HCl
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration curve (AUC)
研究概览
简要总结
The study is a randomized, double-blind, placebo-controlled, dose escalation, first-in-human trial of the safety and tolerability of COR388 HCl in healthy male and female subjects.
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
- Double (Participant, Investigator)
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
- •Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from Day -1 through 28 days after the dose of study drug;
- •Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at screening visit and Day 1; agree to use double-barrier contraceptive measures or avoid intercourse from Day -10 through 28 days after the dose of study drug;
- •Body mass index (BMI) ≥19 to ≤32 kg/m2;
- •Good health as determined by the absence of clinically significant deviation from normal, by medical history, physical examination, laboratory reports, and 12-lead electrocardiogram (ECG) prior to enrollment;
- •Non-smoker and non-tobacco user for a minimum of 3 months prior to screening and for the duration of the study;
- •Able to understand and willing to comply with all study requirements, and follow the study medication regimen.
排除标准
- •History or current evidence of cardiac, hepatic, renal, pulmonary, endocrine, neurologic, gastrointestinal, hematologic, oncologic, infectious, or psychiatric disease as determined by screening history, physical examination, laboratory reports, or 12-lead ECG;
- •Need for any concomitant medication (with the exception of hormonal contraceptives as allowed for females of child-bearing potential);
- •Use of any prescription drug within 14 days prior to the first dose of the study (with the exception of hormonal contraceptives for females of childbearing potential);
- •Use of any non-prescription drug and/or herbal supplements within 7 days prior to the first dose of the study;
- •History of significant allergic reaction to any drug;
- •Participation in another investigational new drug research study within the 30 days prior to the first dose of the study;
- •History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator;
- •Positive urine screen for prohibited drugs or positive alcohol screen on Day -1.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
COR388 TBD mg
Active Comparator
干预措施: COR388 (Drug)
结局指标
主要结局
Area under the plasma concentration curve (AUC)
时间窗: 72 hours
Analysis of AUC
Time of the first occurrence of the maximum observed plasma concentration (Tmax)
时间窗: 72 hours
Analysis of Tmax
Maximum observed plasma concentration (Cmax)
时间窗: 72 hours
Analysis of Cmax
次要结局
- Changes in hematology lab measures (RBC, Hgb, Hct).(72 hours)
- Incidence of treatment emergent adverse events(72 Hours)
- Changes in chemistry lab measures (Sodium [Na], Blood Urea Nitrogen [BUN], Calcium [Ca], Total bilirubin).(72 hours)
- Changes in urinalysis lab parameters (pH, specific gravity, glucose).(72 hours)
研究者
研究点 (1)
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