NCT07034183

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2025

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 19, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

July 30, 2025

Status Verified

June 1, 2025

Enrollment Period

12 months

First QC Date

March 27, 2025

Last Update Submit

July 28, 2025

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent AEs and SAEs as assessed by vital signs

    Measured as count of events.

    42 days (treatment period: 28 days, observation period: 14 days)

Study Arms (4)

Part 1A: Single Ascending Dose

EXPERIMENTAL
Drug: PRD001Drug: Placebo

Part 1B: Dietary effects

EXPERIMENTAL
Drug: PRD001

Part 2A: 14 days Multiple Ascending Dose

EXPERIMENTAL
Drug: PRD001Drug: Placebo

Part 2B: 28 days Multiple Ascending Dose

EXPERIMENTAL
Drug: PRD001Drug: Placebo

Interventions

PRD001DRUG

PRD001 capsules will be provided for oral administration

Part 1A: Single Ascending DosePart 1B: Dietary effectsPart 2A: 14 days Multiple Ascending DosePart 2B: 28 days Multiple Ascending Dose
PlaceboDRUG

Placebo capsules will be provided for oral administration

Part 1A: Single Ascending DosePart 2A: 14 days Multiple Ascending DosePart 2B: 28 days Multiple Ascending Dose

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Part 1A and Part 2A
  • Healthy men aged between 18 and 45 years inclusive at the time of signing the informed consent form (ICF)
  • Individuals who are willing and able to comply with the protocol schedule, including all scheduled visits, treatment plans, laboratory tests, and other trial procedures.
  • 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.
  • 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.
  • 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
  • Men aged between 18 and 60 years inclusive at the time of signing the ICF
  • Individuals who are willing and able to comply with the protocol schedule, including all scheduled visits, treatment plans, laboratory tests, and other trial procedures.
  • 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.
  • Individuals whose parents and maternal and paternal grandparents are Japanese.
  • Individuals who meet the following criteria:
  • i. Individuals with mild-hyper-LDL-cholesterolemia ii. Individuals with mild hepatic steatosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SOUSEIKAI Fukuoka Mirai Hospital

Fukuoka, Fukuoka, Japan

RECRUITING

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2025

First Posted

June 24, 2025

Study Start

June 19, 2025

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

July 30, 2025

Record last verified: 2025-06

Locations

JP(1)