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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05607589
• Other study ID #: DW_DWP213388101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 31, 2022
• Est. completion date: March 8, 2024

Study information

• Verified date: November 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Jongwoo Kim, MS
• Phone: +821053884526
• Email: jwkim0223[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: March 8, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DWP213388
immunosuppressant

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEAE	Incidence and severity	up to 7 days from the last dosing
Primary	12-lead ECG	PR interval, QRS interval, RR interval, QT interval, and QTcF	up to 7 days from the last dosing
Secondary	Cmax	Drug concentration in Blood and urine	up to 72 hours from the last dosing
Secondary	AUC	Area under curve	up to 72 hours from the last dosing
Secondary	CL/F	Clearance	up to 72 hours from the last dosing