Healthy Adult Subjects
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of ID110521156 in healthy adult subjects. This is the first clinical study of ID110521156.
Interventions
DRUGID110521156
subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1
DRUGPlacebo of ID110521156
subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1
Sponsors
YUNOVIA CO.,LTD.
IlDong Pharmaceutical Co Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects aged 19 to 50 years at the time of Screening. * Body mass index (BMI) within 18.5 to 29.9 kg/m2; and a total body weight ≥ 40 kg, ≤ 90 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 hematological, renal, endocrine, pulmonary, gastrointestinal(including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing. * Treatment with an investigational drug (including a bioequivalence study) within 6 months prior to the scheduled date of 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 3 months after the last dose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AEs/serious AEs (SAEs) | Throughout study duration, up to 9 days | Incidence and severity of ad adverse event |
| Percentage of subjects with clinically significant change from baseline in vital signs, ECG, safety laboratory test results | Throughout study duration, up to 9 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf) | Throughout study duration, up to 9 days | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 |
| The time of peak concentration,(Tmax) | Throughout study duration, up to 9 days | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 |
| Terminal half-life (T1/2) | Throughout study duration, up to 9 days | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 |
| Apparent clearance (CL/F) | Throughout study duration, up to 9 days | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 |
| Maximum concentration (Cmax) | Throughout study duration, up to 9 days | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 |
| Amount excreted in urine (Ae) | Throughout study duration, up to 9 days | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 |
| Renal Clearance (CLr) | Throughout study duration, up to 9 days | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 |
| Fraction excreted unchanged of an administered dose (fe) | Throughout study duration, up to 9 days | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 |
| Apparent volume of distribution after extravascular administration (Vd/F) | Throughout study duration, up to 9 days | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 |
| Area under the plasma drug concentration-time curve from 0 to last, (AUClast) | Throughout study duration, up to 9 days | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 |
Countries
South Korea
Outcome results
None listed