NCT07013097

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

A Single-center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PG-033 by Single Dose Administration and Food Effect in Healthy Volunteers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Prime Gene Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single-center, randomized, double-blind, placebo-controlled, single-dose administration, and dose escalation phase I clinical study in adult participants aged from 18 to 45 years old (including threshold) with healthy male and female subjects. The study includs a single dose ascending study (SAD) and a food effect (FE) study. The single ascending dose (SAD) study will be conducted by increasing the dosage from low dosage level to high. Approximately 40 participants will be randomized 3:1 to PG-033 or placebo in 5 dose groups. The food effect study adopts a single-center, randomized, open-label, single-dose, two-period and two-sequence crossover clinical trial design. 12 participants will be randomly divided into group A and group B, with 6 participants in each group. In the first period, the 6 subjects in Group A will take PG-033 on an empty stomach, while the 6 subjects in Group B will take PG-033 after having a high-fat meal. In the second period, the two groups will cross over in taking the drug. That is, the subjects in Group A will take PG-033 after having a high-fat meal, and the subjects in Group B will take PG-033 on an empty stomach. The washout period between the two dosing periods is 7 days.

Conditions

• Lichen Simplex Chronicus

Interventions

Type	Name	Description
DRUG	PG-033	Oral tablets (2mg， 10mg)
DRUG	PG-033 placebo comparator	Oral tablets (2 mg, 10 mg) (matching corresponding study medication)

Timeline

• Start date: 2025-05-23
• Primary completion: 2025-10-31
• Completion: 2025-12-31
• First posted: 2025-06-10
• Last updated: 2025-06-10

Locations

1 site across 1 country: China