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drugset / Trial / NCT07013097

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

NCT07013097 ↗

Phase 1 Recruiting 52 enrolled Prime Gene Therapeutics Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-05-23
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator PG-033 Unknown 2 mg Oral
Comparator PG-033 Unknown 10 mg Oral

Indications

neurodermatitis