CompletedPhase 1ACTRN12620000536965

Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of PLN-74809

A Continued Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of PLN-74809 in Healthy Participants

Sponsor

Pliant Therapeutics, Inc.

Enrollment

80 participants

Start Date

Dec 16, 2019

Study Type

Interventional

Conditions

Primary Sclerosing Cholangitis

Summary

PLN-74809 is being developed for the treatment of idiopathic pulmonary fibrosis (IPF), the most common interstitial lung disease. IPF is a condition usually observed in the elderly characterized by dyspnea and progressive loss of lung function leading to death, with median survival of 3.8 years after diagnosis based on 2014 data in the United States. PLN-74809 is expected to exert anti-fibrotic effects through mechanisms that are different from those of the current standards of care for the treatment of IPF. IPF remains a clear area of unmet medical need, warranting the development of novel therapies aimed at providing a clinically meaningful improvement for the IPF population. The main purpose of the current study is to continue evaluating the safety, tolerability and pharmacokinetics (PK) of single and multiple doses of PLN-74809 in healthy participants.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria6

18 to 55 years
Good general health, with no significant medical history and no clinically significant abnormalities at screening and/or before administration of the initial dose of study drug.
Body weight greater than or equal to 50 kg
Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
Participants must use adequate contraception measures for males and female participants of childbearing potential
Understand the study procedures and agrees to participate in the study by giving written informed consent.

Exclusion Criteria10

History of clinically significant abnormalities or diseases.
Pregnant or lactating females.
Positive test for hepatitis C antibody (HCVAb), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at screening.
Positive toxicology screening panel.
History of substance abuse or dependency or history of recreational drug use.
Alcohol consumption greater than 14 drinks per week for males (7 for females).
Smokers or ‘vapers’ (cigarette or other modalities).
Unable to refrain from or anticipates the use of any medications, including prescription and non-prescription drugs and herbal supplements.
Unlikely to comply with the study protocol or, in the opinion of the Investigator, would not be a suitable candidate for participation in the study.
Have participated in any other investigational drug trial within 30 days or 5 half-lives.

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Interventions

This is a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Phase trial. Participants will be randomised to either orally receive with PLN-74809 or placebo. Active treatment will be PL

This is a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Phase trial. Participants will be randomised to either orally receive with PLN-74809 or placebo. Active treatment will be PLN-74809 Experimental SAD dosing: PLN-74809 or placebo dosed orally, administered once daily for a single dose planned in 4 cohorts of 10 healthy participants per cohort for SAD, assessing a starting dose of 120mg and and increasing the dose for up to three (3x) additional cohorts. The specific dose to be administered to each additional cohort will be determined by the review of the previous cohorts safety and PK data by the study’s Safety Review Committee. Experimental MAD dosing: PLN-74809 or placebo dosed orally, administered once daily for seven days planned in 4 cohorts of 10 healthy participants per cohort for MAD, assessing a starting dose of 60mg and and increasing the dose for up to three (3x) additional cohorts. The specific dose to be administered to each additional cohort will be determined by the review of the previous cohorts safety and PK data by the study’s Safety Review Committee. Protocol excludes subjects who have participated in any other investigational drug trial within 30 days or 5 half-lives (whichever is long) of dosing in present study. Therefore while it is not specifically excluded and it may be possible, it is not the sponsor’s preference to have a subject who participated in the SAD to rescreen/enroll into the MAD dosing cohort. Intervention is administered directly by staff at Phase 1 unit. Laboratory tests will also be monitored to assess adherence retrospectively.