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
Overview
- Phase
- Phase 1
- Intervention
- ID110521156
- Conditions
- Healthy Adult Subjects
- Sponsor
- IlDong Pharmaceutical Co Ltd
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- AEs/serious AEs (SAEs)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
Cohort 1
Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
Intervention: ID110521156
Cohort 1
Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
Intervention: Placebo of 110521156
Cohort 2
Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
Intervention: ID110521156
Cohort 2
Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
Intervention: Placebo of 110521156
Cohort 3
Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
Intervention: ID110521156
Cohort 3
Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
Intervention: Placebo of 110521156
Outcomes
Primary Outcomes
AEs/serious AEs (SAEs)
Time Frame: Throughout study duration, up to 47 days
Secondary Outcomes
- 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)