A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics After a Single Oral Administration 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
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Cohort 1
Cohort 1 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Intervention: ID110521156
Cohort 1
Cohort 1 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Intervention: Placebo of ID110521156
Cohort 2
Cohort 2 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Intervention: ID110521156
Cohort 2
Cohort 2 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Intervention: Placebo of ID110521156
Cohort 3
Cohort 3 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Intervention: ID110521156
Cohort 3
Cohort 3 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo.
Intervention: Placebo of ID110521156
Cohort 4
Cohort 4 will consist of 12 healthy subjects who will receive a single oral dose of ID110521156 at fed state and fasted state each.
Intervention: ID110521156
Outcomes
Primary Outcomes
AEs/serious AEs (SAEs)
Time Frame: 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
Time Frame: Throughout study duration, up to 9 days
Secondary Outcomes
- Maximum concentration (Cmax)(Throughout study duration, up to 9 days)
- Terminal half-life (T1/2)(Throughout study duration, up to 9 days)
- The time of peak concentration,(Tmax)(Throughout study duration, up to 9 days)
- Apparent clearance (CL/F)(Throughout study duration, up to 9 days)
- Area under the plasma drug concentration-time curve from 0 to last, (AUClast)(Throughout study duration, up to 9 days)
- Apparent volume of distribution after extravascular administration (Vd/F)(Throughout study duration, up to 9 days)
- Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf)(Throughout study duration, up to 9 days)
- Amount excreted in urine (Ae)(Throughout study duration, up to 9 days)
- Fraction excreted unchanged of an administered dose (fe)(Throughout study duration, up to 9 days)
- Renal Clearance (CLr)(Throughout study duration, up to 9 days)