Phase I Study to Assess Safety, Tolerability, and Pharmacokinetics of Single Doses of PG-033 Including Effects of High-Fat Meal in Healthy Adults Aged 18 to 45

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of single ascending oral doses of PG-033 in healthy adults aged 18 to 45 years. The study also examines how a high-fat meal affects the pharmacokinetics of PG-033, explores its potential metabolites and metabolic pathways, and investigates its impact on the QTc interval. This is a phase I clinical trial conducted by Prime Gene Therapeutics Co., Ltd. The study includes two parts a single ascending dose SAD study and a food effect FE study. In the SAD study, about 40 participants are randomized in a 31 ratio to receive either PG-033 or a placebo across five dose levels, increasing from low to high. The FE study is a two-period, two-sequence crossover design involving 12 participants divided into two groups, who receive PG-033 either on an empty stomach or after a high-fat meal, with a 7-day washout period between doses. Participants will undergo safety and tolerability assessments for up to 7 days in the SAD study and 14 days in the FE study. Researchers will measure pharmacokinetic parameters such as Cmax, Tmax, AUC, half-life, volume of distribution, clearance, and mean residence time within 3 days post-dose. The QT interval will be monitored up to 24 hours after dosing. Screening includes vital signs, laboratory tests, chest X-ray, and ultrasound to confirm health status. Participants will be monitored closely for any adverse effects throughout the study.

A Phase I Clinical Trial to Evaluate the Single Dose Ascending and Food Effects of PG-033 in Healthy Adults