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A First-in-Human Study of PRD001 in Healthy Men Assessing Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses
Led by PRD Therapeutics, Inc. · Updated on 2025-07-30
86
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying PRD001 to assess its safety, tolerability, and how it behaves in the body (pharmacokinetics) in healthy men and men with mild high LDL cholesterol and mild fatty liver. This Phase 1 trial aims to better understand how PRD001 works in different groups, including healthy volunteers and those with borderline to mild lipid and liver conditions. The study is sponsored by PRD Therapeutics, Inc. and includes men aged 18 to 60 years. The trial is randomized and quadruple-masked to ensure unbiased results. Participants will receive oral capsules of PRD001 or placebo. The study has multiple parts: Part 1A involves single ascending doses, Part 1B looks at dietary effects after Part 1A, Part 2A includes 14 days of multiple ascending doses, and Part 2B includes 28 days of multiple ascending doses in men with mild hyper-LDL-cholesterolemia and mild fatty liver. Each part follows specific schedules of dosing and assessments to monitor effects. During the study, participants will undergo various assessments including vital signs, physical examinations, electrocardiograms, and laboratory tests. Researchers will track treatment-emergent adverse events and serious adverse events over 42 days, covering 28 days of treatment and 14 days of observation. Participants must comply with scheduled visits, treatment plans, and tests throughout the study period, which extends until 2026. Safety and tolerability are closely monitored to understand the impact of PRD001.
CONDITIONS
Brief Title
A First-in-Human Study of PRD001
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18 to 45 years for Part 1A and Part 2A
- Men aged 18 to 60 years for Part 2B
- Willing and able to follow the study schedule, including visits, treatments, and tests
- Generally healthy with no diseases requiring medical treatment, confirmed by medical history, exams, ECG, and labs
- For Japanese participants in Parts 1A and 2A, parents and grandparents must be Japanese
- For Caucasian participants in Part 2A, parents and grandparents must be Caucasian
- For Part 1B, completion of Part 1A with PRD001 and visit schedules
- For Part 2B, mild hyper-LDL-cholesterolemia and mild hepatic steatosis
- For Part 2B, parents and grandparents must be Japanese
You will not qualify if you...
- Active, latent, or inadequately treated tuberculosis infection
- Positive tuberculosis test (QuantiFERON-TB Gold or equivalent) or untreated tuberculosis
- History of HIV infection
- History of syphilitic infection
- History of hepatitis B or hepatitis C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days depending on the study part
Participants receive single and multiple oral doses of PRD001 or placebo to assess safety, tolerability, and pharmacokinetics.
Multiple visits during dosing period
Duration - 14 days
Participants are monitored for safety and adverse events after completing treatment.
Visits during observation period
Trial Site Locations
Total: 1 location
1
SOUSEIKAI Fukuoka Mirai Hospital
Fukuoka, Fukuoka, Japan
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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