Clinical Trial

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

Recruiting Phase 1
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Summary
The goal of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) profiles of single ascending oral doses(SAD) of PG-033 by directly comparing it with placebo. Meanwhile, the impact of a high-fat meal on the pharmacokinetics of PG-033 will also be evaluated. The research will also explore the potential metabolites and metabolic pathways of PG-033 within the human body，as well as investigate the effect of PG-033 on the QTc interval.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-05.
Trial Details
NCT Number NCT07013097
Lead Sponsor Prime Gene Therapeutics Co., Ltd.
Conditions Lichen Simplex Chronicus
Enrollment 52 participants
Start Date 2025-05-23
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-02