A Phase 1, Single-center, Open-label, Study to Investigate the Safety, Tolerability, and Pharmacokinetics of a Single Dose and Multiple Doses of EDG-7500 in Healthy Adult Caucasian and Japanese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax,ss
研究概览
简要总结
The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after single and multiple doses in Japanese and Caucasian adults. The safety of EDG-7500 in these adult participants will also be evaluated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Adult, male or female, 18-55 years of age, inclusive.
- •Medically healthy based on a medical evaluation (including medical history, physical examination, vital signs measurement, 12-lead ECG, and clinical laboratory evaluations) performed at screening.
- •Meets the protocol-specified criteria to qualify as a Japanese or Caucasian participant.
- •BMI ≥ 18.0 and ≤ 35.0 kg/m2 at screening.
- •Heart rate ≥ 45 and ≤ 99 bpm, systolic blood pressure ≥90 and <140 mmHg, and diastolic blood pressure ≥ 50 to ≤ 90 mmHg at screening.
- •eGFR ≥ 80 mL/min/1.73 m2 calculated using the CKD-EPI formula at screening.
- •Female and male participants must follow protocol-specified contraception guidance.
排除标准
- •History or evidence of any clinically significant cardiovascular, dermatologic, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, neurologic, psychiatric, pulmonary, renal, respiratory, and/or other major disorders or malignancy.
- •History or evidence of any disorder that may interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV).
- •History of significant blood loss, donation of blood, or received a transfusion of any blood or blood products within 60 days prior to screening.
- •History of plasma donation within 7 days prior to screening.
- •History of use of tobacco- or nicotine-containing products within six months prior to screening.
- •Participating in another interventional clinical study or has used an investigational drug within 30 days or 5 half-lives prior to screening.
- •History of alcohol and/or illicit drug abuse within 2 years of study participation.
- •Positive urine test for alcohol or a positive urine drug test at screening or check-in.
- •Breastfeeding or has a positive serum pregnancy test at screening or check-in.
研究组 & 干预措施
Cohort 3 - Healthy Caucasian Adults
Single and Multiple Dose EDG-7500
干预措施: EDG-7500 (Drug)
Cohort 1 - Healthy Japanese Adults
Single and Multiple Dose EDG-7500
干预措施: EDG-7500 (Drug)
Cohort 2 - Healthy Japanese Adults
Single and Multiple Dose EDG-7500
干预措施: EDG-7500 (Drug)
结局指标
主要结局
Cmax,ss
时间窗: Day 1 to Day 13
Maximum plasma concentration at steady state determined directly from the concentration-time profile
AUCtau
时间窗: Day 1 to Day 13
Area under the concentration-time curve during the dosing interval
AUC0-last
时间窗: Day 1 to Day 13
Area under the plasma concentration time-curve from time zero to the last measured concentration
AUC0-inf
时间窗: Day 1 to Day 13
Area under the plasma concentration time-curve from time zero extrapolated to infinity
Cmax
时间窗: Day 1 to Day 13
Maximum plasma concentration observed
次要结局
- Safety - TEAEs(Up to 23 days of monitoring)
- Tmax(Day 1 to Day 13)
- AUC%extrap(Day 1 to Day 13)
- CL/F(Day 1 to Day 13)
- Vz/F(Day 1 to Day 13)
- T1/2(Day 1 to Day 13)
- Ctrough,ss(Day 1 to Day 13)
- Cavg,ss(Day 1 to Day 13)
- RA(AUCtau)(Day 1 to Day 13)
- RA(Cmax)(Day 1 to Day 13)