NCT07034183

A First-in-Human Study of PRD001

A First-in-Human Study of PRD001 in Healthy Participants, Assessment of Safety, Tolerability and Pharmacokinetics of Single/Multiple Doses

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: PRD Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of PRD001 in healthy participants and to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of PRD001 in participants with borderline/mild hyper-LDL-cholesterolemia and mild fatty liver.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	PRD001	PRD001 capsules will be provided for oral administration
DRUG	Placebo	Placebo capsules will be provided for oral administration

Timeline

• Start date: 2025-06-19
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-06-24
• Last updated: 2025-07-30

Locations

1 site across 1 country: Japan