Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
86 participants
INTERVENTIONAL
2025-06-19
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Part 1A: Single Ascending Dose
PRD001
PRD001 capsules will be provided for oral administration
Placebo
Placebo capsules will be provided for oral administration
Part 1B: Dietary effects
PRD001
PRD001 capsules will be provided for oral administration
Part 2A: 14 days Multiple Ascending Dose
PRD001
PRD001 capsules will be provided for oral administration
Placebo
Placebo capsules will be provided for oral administration
Part 2B: 28 days Multiple Ascending Dose
PRD001
PRD001 capsules will be provided for oral administration
Placebo
Placebo capsules will be provided for oral administration
Interventions
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PRD001
PRD001 capsules will be provided for oral administration
Placebo
Placebo capsules will be provided for oral administration
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
MALE
Yes
Sponsors
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PRD Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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SOUSEIKAI Fukuoka Mirai Hospital
Fukuoka, Fukuoka, Japan
Countries
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Facility Contacts
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Other Identifiers
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PRD001-101-J
Identifier Type: -
Identifier Source: org_study_id
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