Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties of DWN12088 following Oral Administration in Healthy Volunteers

Phase 1

Completed

• Conditions: Idiopathic Pulmonary Fibrosis (IPF); Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12619001239156
• Lead Sponsor: Daewoong Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-09
• Study Completion: 2020-11-16
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Body mass index between 18.0, lesser than or equal to Body Mass Index (BMI) lesser than or equal to 30.0 at screening
2. Subjects who are determined to be in good health based on the results of medical history, physical examinations, 12-lead ECG, vital signs measurement, and clinical laboratory evaluations (congenital diseases are excluded) at screening or Day -1 as assessed by the Investigator (or designee)
3. Willing to sign 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.
4.Eligible to participate in the study at the discretion of the investigator following medical examination by interview, physical examination and review of laboratory test results.
5.Female subjects must be either post-menopausal or, if pre-menopausal, must have a negative urinary or serum pregnancy test and agree to use 2 forms of contraception (as below) from screening until 90 days after the last dose of IP.
Male subjects must be surgically sterile (vasectomy at least 6 months prior to screening), or if sexually active and having a pre-menopausal female partner, must agree to use 2 forms of contraception (as below) from the date of dosing and for 90 days after the last dose of the IP. They must also refrain from donating sperm from the date of first dosing until 90 days after the last dose of the IP.

Exclusion Criteria

Exclusion criteria
1.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).
2.Fasting blood glucose greater than 110 mg/dL (greater than 6.1 mmol/L) (confirmed with repeat testing).
3.History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
4.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).
5.The subject has a substance abuse-related disorder or has a history of drug and/or alcohol and/or substance abuse deemed significant by the Investigator (or designee).
6.Positive urine drug screen (including nicotine) at Screening and Day -1. If result obtained during screening is positive, it can be repeated at Day -1.
7.Use of nicotine-containing products within 90 days prior to screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified