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

NCT05607589 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: DW_DWP213388101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Cmax

  up to 72 hours from the last dosing

• AUC

  up to 72 hours from the last dosing

• CL/F

  up to 72 hours from the last dosing

Study Arms (2)

DWP213388

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

DWP213388 DRUG

immunosuppressant

DWP213388

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Officials

• Goldwater Ronald

  Parexel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 7, 2022
• Study Start: October 1, 2022
• Primary Completion: February 20, 2024
• Study Completion: March 8, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11