Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult Subjects
- Conditions
- Healthy Adult Subjects
- Interventions
- Drug: Placebo of 110521156
- Registration Number
- NCT06635226
- Lead Sponsor
- IlDong Pharmaceutical Co Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 3 ID110521156 Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) Cohort 1 ID110521156 Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) Cohort 1 Placebo of 110521156 Cohort 1 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) Cohort 2 ID110521156 Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) Cohort 2 Placebo of 110521156 Cohort 2 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients) Cohort 3 Placebo of 110521156 Cohort 3 will consist of 12 healthy subjects, randomly assigned to ID110521156 (10 patients) or its placebo (2 patients)
- Primary Outcome Measures
Name Time Method AEs/serious AEs (SAEs) Throughout study duration, up to 47 days
- Secondary Outcome Measures
Name Time Method Maximum concentration of drug in plasma (Cmax) Day 1 and Day 28 To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Area under the plasma drug concentration-time curve during a dosing interval (AUCtau) Day 1 and Day 28 To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
The time of peak concentration (Tmax) Day 1 and Day 28 To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Terminal half-life (t1/2) Day 1 and Day 28 To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Apparent clearance (CL/F) Day 1 and Day 28 To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Apparent volume of distribution after extravascular administration (Vd/F) Day 1 and Day 28 To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Renal clearance (CLR) Day 1 and Day 28 To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
fe Day 1 and Day 28 To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Trough plasma concentration taken directly before the next dose (Ctrough) Throughout study duration, up to 27 days To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Minimum concentration of drug in plasma at steady state (Cmin, ss) Day 28 To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
Average concentration of drug in plasma at steady state (Cavg, ss) Day 28 To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
peak to trough fluctuation (PTF) Day 28 To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
accumulation ratio (R) Day 28 To assess the PK of ID110521156 when given at multiple ascending doses in healthy participants.
Serum glucose up to 28 days To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants.
Insulin up to 28 days To assess the pharmacodynamics of ID110521156 when given at single and multiple ascending doses in healthy participants.
Hemoglobin A1c (HbA1c) up to 47 days To assess the pharmacodynamics of ID110521156 when given at multiple ascending doses in healthy participants.
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of