Single Ascending Oral Dose Phase 1 Study of ID11052 in Healthy Adult Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of ID110521156 in healthy adult sbujects. This is the first clinical study of ID110521156.

Official Title
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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

Conditions
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Healthy Adult Subjects

Intervention / Treatment
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* Drug: ID110521156
* Drug: Placebo of ID110521156


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects aged 19 to 55 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 hasbeen 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 (includingdrug 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 forthe duration of the study and for at least 3 months after the last dose.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>The study will consist 4 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. | Drug: ID110521156<br>* 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<br>Drug: Placebo of ID110521156<br>* 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<br>* Other names: Placebo;|
| Experimental: Cohort 2<br>The study will consist 4 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. | Drug: ID110521156<br>* 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<br>Drug: Placebo of ID110521156<br>* 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<br>* Other names: Placebo;|
| Experimental: Cohort 3<br>The study will consist 4 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. | Drug: ID110521156<br>* 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<br>Drug: Placebo of ID110521156<br>* 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<br>* Other names: Placebo;|
| Experimental: Cohort 4<br>The study will consist 4 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. | Drug: ID110521156<br>* 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<br>Drug: Placebo of ID110521156<br>* 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<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs/serious AEs (SAEs) | Incidence and severity of ad adverse event | Throughout study duration, up to 9 days | 
| Percentage of subjects with clinically significant change from baselin in vital signs, ECG, safety laboratory test restuls |  | Throughout study duration, up to 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days | 
| Area under the plasma drug concentration-time curve from 0 to last, (AUClast) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days | 
| Area under the plasma drug concentration-time curve from 0 to infinity (AUCinf) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days | 
| The time of peak concentration,(Tmax) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days | 
| Terminal half-life (T1/2) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days | 
| Apparent clearance (CL/F) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days | 
| Apparent volume of distribution after extravascular administration (Vd/F) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days | 
| Amount excreted in urine (Ae) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days | 
| Renal Clearance (CLr) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days | 
| Fraction excreted unchanged of an administered dose (fe) | Both plasma and urine PK of ID110521156 will be assessed after single dose administration of ID110521156 | Throughout study duration, up to 9 days |