The Safety, Tolerability, PK, and PD of DWP213388 After SAD and MAD Administration in Healthy Adult Subjects

Study Overview
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Brief Summary
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A Phase 1, First-in-human, Randomized, Double-blind, Placebo controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DWP213388 after Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects

Detailed Description
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DWP213388 will be administered to the study subjects, according to a randomized, double-blind, and placebo-controlled design. The administration will be a single or multiple oral doses for healthy subjects.

Official Title
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A Phase 1, First-in-human, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DWP213388 After SAD and MAD in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: DWP213388
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to sign an Institutional Review Board (IRB) approved informed consent form (ICF) on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any screening procedure being undertaken. Healthy adult male or female subject, of any race, between 18 to 65 years of age, inclusive at time of signing the ICF and prior to study intervention administration. Body mass index (BMI) between 18.0 and 34.9 kg/m2 at Screening. Subject who is determined to be in good health based on the results of medical history, physical examinations, 12-lead ECG, vital signs, and clinical laboratory evaluations at Screening or Day -1 as assessed by the Investigator (or designee). Exclusion Criteria: Subject has significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). attacks Subject has fasting blood glucose > 110 mg/dL (> 6.1 mmol/L) (confirmed with repeat testing if required) at Screening. Subject has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note subjects with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee). Subject has a history of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP213388<br>Each cohort, healthy subjects will be administered DWP213388 (6 subjects per each cohort) SAD Cohort 1: DWP213388 x mg QD Cohort 2: DWP213388 x mg QD Cohort 3: DWP213388 x mg QD Cohort 4: DWP213388 x mg QD Cohort 5: DWP213388 x mg QD MAD Cohort 6: DWP213388 x mg QD Cohort 7: DWP213388 x mg QD Cohort 8: DWP213388 x mg QD Cohort 9: DWP213388 x mg QD | Drug: DWP213388<br>* immunosuppressant<br>|
| Placebo Comparator: Placebo<br>Each cohort, healthy subjects will be administered placebo (2 subjects per each cohort) SAD Cohort 1: Placebo QD Cohort 2: Placebo QD Cohort 3: Placebo QD Cohort 4: Placebo QD Cohort 5: Placebo QD MAD Cohort 6: Placebo QD Cohort 7: Placebo QD Cohort 8: Placebo QD Cohort 9: Placebo QD | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEAE | Incidence and severity | up to 7 days from the last dosing | 
| 12-lead ECG | PR interval, QRS interval, RR interval, QT interval, and QTcF | up to 7 days from the last dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Drug concentration in Blood and urine | up to 72 hours from the last dosing | 
| AUC | Area under curve | up to 72 hours from the last dosing | 
| CL/F | Clearance | up to 72 hours from the last dosing |