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A First-in-Human Study of PRD001

NCT07034183 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-07-30

No results posted yet for this study

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

DRUG

PRD001

PRD001 capsules will be provided for oral administration

DRUG

Placebo

Placebo capsules will be provided for oral administration

Sponsors & Collaborators

  • PRD Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-19
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Japan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07034183 on ClinicalTrials.gov