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RECRUITING
NCT07013097
PHASE1

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

Sponsor: Prime Gene Therapeutics Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2025-05-23

Completion Date

2025-12-31

Last Updated

2025-06-10

Healthy Volunteers

Yes

Interventions

DRUG

PG-033

Oral tablets (2mg, 10mg)

DRUG

PG-033 placebo comparator

Oral tablets (2 mg, 10 mg) (matching corresponding study medication)

Locations (1)

Beijing Shijitan Hospital , Capital Medical University

Beijing, Beijing Municipality, China