PK data from first 3 cohorts does not support study continuation.There was no safety concerns

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of PBI-4547 in healthy adult participants.

This is a first-in-human, single-ascending dose study of PBI-4547 in healthy adult participants. PBI-4547 is a synthetic ligand of G protein-coupled receptor (GPR)40 and GPR84, which have been reported to play a role in fibrosis in various animal models as well as in tissue culture.

A total of 40 healthy adult participants will sequentially receive 1 of 5 doses of PBI-4547 (Dose1, 2, 3, 4 or 5) or matching placebo, with each cohort of 8 participants randomized in a 3:1 ratio to receive PBI-4547 or matching placebo.

A food-effect cohort will be added after review of the PK results of at least the first dose, and the following 2 doses, if needed. In this cohort participants will initially receive the study drug under fasting conditions (Period 1) followed by the same dose after the ingestion of a high-fat meal (Period 2) after a 14-day washout period.

Inclusion Criteria:

• Healthy male participants or non-childbearing potential female participants, ≥18 and ≤55 years.
• Body mass index > 18.5 and < 30.0 kg/m^2, and body weight ≥ 50.0 kg for male participants and ≥ 45.0 kg for female participants.
• Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to screening.
• Male participants with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after study drug administration.
• Male participants must be willing not to donate sperm until 90 days after study drug administration.

Exclusion Criteria:

• Any clinically significant abnormality or abnormal laboratory test results.
• An estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m^2.
• Positive urine drug screen and history of significant drug abuse.
• History of significant allergic reactions to any drug.
• Use of any drugs known to induce or inhibit hepatic drug metabolism.
• Positive pregnancy test or breast-feeding participant.
• Clinically significant abnormalities in ECG, blood pressure, and heart rate at screening.
• History of significant alcohol abuse or regular use of alcohol.
• Use of medication other than topical products without significant systemic absorption.
• Donation of plasma.