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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2024-03-08

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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DWP213388

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

Group Type EXPERIMENTAL

DWP213388

Intervention Type DRUG

immunosuppressant

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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DWP213388

immunosuppressant

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. 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.
3. Body mass index (BMI) between 18.0 and 34.9 kg/m2 at Screening.
4. 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

1. 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).

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2. Subject has fasting blood glucose \> 110 mg/dL (\> 6.1 mmol/L) (confirmed with repeat testing if required) at Screening.
3. 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).
4. 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes