The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of ID110521156 in healthy adult subjects.
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.
Sequential
ID110521156
DrugID110521156 capsules taken orally once daily
Placebo of 110521156
DrugID110521156 placebo capsules taken orally once daily
AEs/serious AEs (SAEs)
Maximum concentration of drug in plasma (Cmax)
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)
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
The time of peak concentration (Tmax)
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
Terminal half-life (t1/2)
To assess the PK of ID110521156 when given at single and multiple ascending doses in healthy participants.
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IlDong Pharmaceutical Co Ltd
Lead sponsor
YUNOVIA CO.,LTD.
Collaborator
