RecruitingPhase 1

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

China52 participantsStarted 2025-05-23

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓.Male or female aged 18 to 45 (including threshold). 3. For male subjects, the body weight should be ≥ 50.0 kg, and for female subjects, the body weight should be ≥ 45.0 kg. The body mass index (BMI) should be within the range of 19.0 to 26.0 kg/m²(including threshold).

What they're measuring

Safety and tolerability of PG-033 tablets

Timeframe: Single Ascending Dose study: 7 days；Food Effect study: 14 days

Trial details

NCT IDNCT07013097

SponsorPrime Gene Therapeutics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-31

Contact for this trial

Xiaohua Hao Beijing Shijitan Hospital Affiliated to Capital Medical Univer

+86 13466590802 xiaohualuck@sina.com

View on ClinicalTrials.gov More Lichen Simplex Chronicus trials