A Randomized, Double-blinded, Placebo-controlled, Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Oral Administrations of ID110521156 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AEs/serious AEs (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects aged 19 to 50 years at the time of Screening.
- •Body mass index (BMI) within ≥27 kg/m2; and a total body weight ≥ 50 kg
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- •For female subjects, not pregnant or lactation women, or naturally menopausal (spontaneous amenorrhea for at least 12 months) or surgically infertility (bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy etc).
排除标准
- •Evidence or history of clinically significant hepatic, renal, neurological, immunological, pulmonary, gastrointestinal (including pancreatitis), endocrine, hematological, cardiovascular, urinary, psychiatric disease, sexual dysfunction or drug allergies.
- •Treatment with an investigational drug (including a bioequivalence study) within 180 days prior to the scheduled date of first administration of the investigational product.
- •Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 90 days after the last dose.
研究组 & 干预措施
Cohort 1
Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
干预措施: ID110521156 (Drug)
Cohort 1
Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
干预措施: Placebo of 110521156 (Drug)
Cohort 2
Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
干预措施: ID110521156 (Drug)
Cohort 2
Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
干预措施: Placebo of 110521156 (Drug)
Cohort 3
Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
干预措施: ID110521156 (Drug)
Cohort 3
Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
干预措施: Placebo of 110521156 (Drug)
结局指标
主要结局
AEs/serious AEs (SAEs)
时间窗: Throughout study duration, up to 47 days
次要结局
- Maximum concentration of drug in plasma (Cmax)(Day 1 and Day 28)
- Area under the plasma drug concentration-time curve during a dosing interval (AUCtau)(Day 1 and Day 28)
- The time of peak concentration (Tmax)(Day 1 and Day 28)
- Terminal half-life (t1/2)(Day 1 and Day 28)
- Apparent clearance (CL/F)(Day 1 and Day 28)
- Apparent volume of distribution after extravascular administration (Vd/F)(Day 1 and Day 28)
- Renal clearance (CLR)(Day 1 and Day 28)
- fe(Day 1 and Day 28)
- Trough plasma concentration taken directly before the next dose (Ctrough)(Throughout study duration, up to 27 days)
- Minimum concentration of drug in plasma at steady state (Cmin, ss)(Day 28)
- Average concentration of drug in plasma at steady state (Cavg, ss)(Day 28)
- peak to trough fluctuation (PTF)(Day 28)
- accumulation ratio (R)(Day 28)
- Serum glucose(up to 28 days)
- Insulin(up to 28 days)
- Hemoglobin A1c (HbA1c)(up to 47 days)