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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorPrime Gene Therapeutics Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

1. Read, understood, and signed an ICF before any investigational procedure(s) are performed.

Disqualifiers

1. Participants with abnormal electrocardiogram results during screening (e.g., QT/QTcF > 440 ms, PR interval > 200 ms, QRS complex duration > 100 ms, clinically significant abnormalities of the P wave, clinically significant changes in the ST-T wave, etc.).

Trial design

Treatments tested in this trial

  • PG-033
  • PG-033 placebo comparator

Treatment groups

52 Participants
are divided into 2 treatment groups