Actively Recruiting
A First-in-Human Study of PRD001
Led by PRD Therapeutics, Inc. · Updated on 2025-07-30
86
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A First-in-Human Study of PRD001
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy men aged 18 to 45 years for Part 1A and Part 2A
- Willing and able to follow all study visits, treatments, tests, and procedures
- Able to participate in Part 1B after Part 1A and follow all protocol requirements
- Generally healthy with no disease needing medical treatment based on medical history, physical exam, vital signs, ECG, and lab tests at screening
- For Japanese participants, parents and grandparents must be Japanese; for Caucasians in Part 2A, parents and grandparents must be Caucasian
- For Part 1B, completed all visits after receiving PRD001 in Part 1A
- Men aged 18 to 60 years for Part 2B
- Generally healthy with no disease needing medical treatment (diet or exercise therapy allowed) based on medical history, physical exam, vital signs, ECG, and lab tests at screening
- Parents and grandparents must be Japanese for Part 2B
- Have mild hyper-LDL-cholesterolemia and mild hepatic steatosis
You will not qualify if you...
- Active, latent, or inadequately treated tuberculosis infection at screening
- Positive QuantiFERON-TB Gold test or equivalent
- Untreated, inadequately treated, or currently treated active tuberculosis infection
- History of HIV infection, syphilis, hepatitis B, or hepatitis C at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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