CompletedPhase 1ACTRN12619001239156

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

A Randomized, Double-blind, Placebo-controlled, Single- and Multiple-ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties of DWN12088 following Oral Administration in Healthy Volunteers

Sponsor

Daewoong Pharmaceutical Co., Ltd.

Enrollment

80 participants

Start Date

Sep 10, 2019

Study Type

Interventional

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Summary

This first in human (FIH) Phase I study is a prospective, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability and PK of single and multiple oral ascending doses of DWN12088 in healthy subjects. This study will be conducted in two parts. Part 1: SAD & Part 2: MAD

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 64 Yearss

Inclusion Criteria6

Body mass index between 18.0, lesser than or equal to Body Mass Index (BMI) lesser than or equal to 30.0 at screening
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)
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.
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.
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 Criteria7

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).
Fasting blood glucose greater than 110 mg/dL (greater than 6.1 mmol/L) (confirmed with repeat testing).
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
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).
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).
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.
Use of nicotine-containing products within 90 days prior to screening.

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Interventions

This first in human (FIH) Phase I study and this study will be conducted in two parts. • Part 1: SAD: 48 subjects (6 cohorts) • Part 2: MAD: 32 subjects (4 cohorts) Part 1: Part 1 will be condu

This first in human (FIH) Phase I study and this study will be conducted in two parts. • Part 1: SAD: 48 subjects (6 cohorts) • Part 2: MAD: 32 subjects (4 cohorts) Part 1: Part 1 will be conducted in healthy subjects. Forty Eight(48) subjects will be enrolled, 8 subjects in each of 6 cohorts, including 2 receiving placebo (as oral solution or enteric-coated capsule or enteric-coated tablets) and 6 receiving DWN12088 (as oral solution or enteric-coated capsule or enteric-coated tablets), after at least 10 hours of fasting, 10 hour fast from solids is required, fasting requirements will be discussed during visits, fasting state will also be maintained during participant inpatient stay and observation. The proposed doses of DWN12088 are between 100 ~ 800 mg. An intermediate dose level may be administered in place of the planned dose levels, if it is deemed appropriate to ensure the safety or increase the scientific value of this Phase I study. Approximate escalation varies and the planned dose levels are – 100mg & 200mg DWN12088/placebo provided as enteric-coated capsules, and 500 mg and 800 mg with DWN12088/placebo provided as enteric-coated tablets. Dose escalation or dose expansion can be done based on safety recommendations from each SRC. Duration of Treatment: Part 1- SAD cohort will be Day 8 (+2 days). Part 2 Part 2 will be conducted in healthy subjects, Thirty-two (32) subjects will be enrolled, 8 subjects in each of 4 sequential dose groups, including 2 receiving placebo and 6 receiving DWN12088 (enteric coated tablets) will be administered twice per day from Day 1 to Day 13 and only in the morning on Day 14. Doses within the same day are to be administered 12 hours apart, and if there is any delay in dosing, the next DWN12088/placebo dosing should revert to Day 1 dosing timing. On Day 1 and Day 14 only, the morning oral dose of DWN12088/placebo will be administered after at least 10 hours of fasting. The proposed doses of DWN12088 are between 25 ~ 300 mg. These doses and/or schedule may be adjusted based on review of the safety data by the SRC. However, the maximum dose will not exceed the maximum dose determined by SRC in Part 1. An intermediate dose level may be administered in place of the planned dose levels, if it is deemed appropriate to ensure the safety or increase the scientific value of this Phase I study. Approximate escalation varies and the planned dose levels are – 25mg, 75mg, 150mg, 300mg. Additional cohort(s) may be planned based on SRC recommendations. Dose escalation or dose expansion can be done based on safety recommendations from SRC. Duration of Treatment: Part 2- MAD cohort will be 21 (+2 days). Study populations are distinct and participants can only participant in Part 1 or Part 2. Study drug compliance will be checked by direct observation by study personnel.