A First-in-Human Study of PRD001

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: PRD001; Drug: Placebo

• Registration Number: NCT07034183
• Lead Sponsor: PRD Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-27
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-13
• Study Start: 2025-06-19
• Study First Posted: 2025-06-24
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-30
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 86

Inclusion Criteria

• Part 1A and Part 2A

  1. Healthy men aged between 18 and 45 years inclusive at the time of signing the informed consent form (ICF)
  2. Individuals who are willing and able to comply with the protocol schedule, including all scheduled visits, treatment plans, laboratory tests, and other trial procedures.
  3. Individuals who are able to participate in Part 1B following Part 1A, and are willing and able to comply with the protocol schedule, including all scheduled visits, treatment plans, laboratory tests, and other trial procedures.
  4. Individuals who have no clinically significant findings, are generally healthy and have no disease requiring medical treatment, based on medical history, physical examinations, vital signs, 12-lead ECG, and laboratory test results at screening.
  5. For Japanese participants in Part 1A and Part 2A, individuals whose parents and maternal and paternal grandparents are Japanese, and for Caucasian participants in Part 2A, individuals whose parents and maternal and paternal grandparents are Caucasian.

• Part 1B Individuals who receive PRD001 in Part 1A and complete all specified visit schedules.

• Part 2B

  1. Men aged between 18 and 60 years inclusive at the time of signing the ICF

  2. Individuals who are willing and able to comply with the protocol schedule, including all scheduled visits, treatment plans, laboratory tests, and other trial procedures.

  3. Individuals who have no clinically significant findings, are generally healthy and have no disease requiring medical treatment (however, diet or exercise therapy is acceptable), based on medical history, physical examinations, vital signs, 12-lead ECG, and laboratory test results at screening.

  4. Individuals whose parents and maternal and paternal grandparents are Japanese.

  5. Individuals who meet the following criteria:

     i. Individuals with mild-hyper-LDL-cholesterolemia ii. Individuals with mild hepatic steatosis

Exclusion Criteria

• All parts

  1. Individuals with active, latent, or inadequately treated M. tuberculosis infection at screening who meet both of the following:

     i. A positive result on the QuantiFERON-TB Gold test or an equivalent test ii. Active tuberculosis infection that is untreated, inadequately treated, or currently being treated

  2. Individuals with a history of human immunodeficiency virus (HIV) infection, syphilitic infection, hepatitis B or C at screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1A: Single Ascending Dose	PRD001	-
Part 1A: Single Ascending Dose	Placebo	-
Part 1B: Dietary effects	PRD001	-
Part 2A: 14 days Multiple Ascending Dose	PRD001	-
Part 2A: 14 days Multiple Ascending Dose	Placebo	-
Part 2B: 28 days Multiple Ascending Dose	PRD001	-
Part 2B: 28 days Multiple Ascending Dose	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent AEs and SAEs as assessed by vital signs	42 days (treatment period: 28 days, observation period: 14 days)	Measured as count of events.

Trial Locations

Locations (1)

SOUSEIKAI Fukuoka Mirai Hospital; 🇯🇵 Fukuoka, Japan