Healthy VolunteersPhase 1NCT07034183
A First-in-Human Study of PRD001
A Phase 1 study testing PRD001 in people with Healthy Volunteers, run by PRD Therapeutics, Inc. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PRD001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteJapan
- Study dates
- 19 Jun 2025to Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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:
- Individuals with mild-hyper-LDL-cholesterolemia ii. Individuals with mild hepatic steatosis
Who cannot join
- All parts
- Individuals with active, latent, or inadequately treated M. tuberculosis infection at screening who meet both of the following:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
SOUSEIKAI Fukuoka Mirai Hospital
Fukuoka, Fukuoka
PharmaLex Japan Inc., +81-3-4590-9005, kazuhiro.kanmuri@pharmalex.com
About this study
Official title: A First-in-Human Study of PRD001 in Healthy Participants, Assessment of Safety, Tolerability and Pharmacokinetics of Single/Multiple Doses
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
- Healthy Volunteers
- Being tested
- PRD001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRD001Drug
PRD001 capsules will be provided for oral administration
PlaceboDrug
Placebo capsules will be provided for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part 1A: Single Ascending Dose | Experimental | Not described Receives: Drug: PRD001; Drug: Placebo |
| Part 1B: Dietary effects | Experimental | Not described Receives: Drug: PRD001 |
| Part 2A: 14 days Multiple Ascending Dose | Experimental | Not described Receives: Drug: PRD001; Drug: Placebo |
| Part 2B: 28 days Multiple Ascending Dose | Experimental | Not described Receives: Drug: PRD001; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent AEs and SAEs as assessed by vital signs
Measured as count of events.
Measured: 42 days (treatment period: 28 days, observation period: 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start19 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PRD Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034183
- Sponsor's protocol ID
- PRD001-101-J
- Status last verified
- Jun 2025
- First submitted
- 27 Mar 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study of PRD001 in Healthy Participants, Assessment of Safety, Tolerability and Pharmacokinetics of Single/Multiple Doses
- ClinicalTrials.gov ID
- NCT07034183
- Acronym / sponsor ID
- PRD001-101-J
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- PRD Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1A: Single Ascending Dose | Experimental | Drug: PRD001, Drug: Placebo |
| Part 1B: Dietary effects | Experimental | Drug: PRD001 |
| Part 2A: 14 days Multiple Ascending Dose | Experimental | Drug: PRD001, Drug: Placebo |
| Part 2B: 28 days Multiple Ascending Dose | Experimental | Drug: PRD001, Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Part 1A and Part 2A
- Part 1B Individuals who receive PRD001 in Part 1A and complete all specified visit schedules.
- Part 2B
Key exclusion criteria (4 listed)
- All parts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRD001PRD001 capsules will be provided for oral administration | Drug | Part 1A: Single Ascending Dose, Part 1B: Dietary effects, Part 2A: 14 days Multiple Ascending Dose, Part 2B: 28 days Multiple Ascending Dose |
| PlaceboPlacebo capsules will be provided for oral administration | Drug | Part 1A: Single Ascending Dose, Part 2A: 14 days Multiple Ascending Dose, Part 2B: 28 days Multiple Ascending Dose |
Primary outcome
Incidence of treatment-emergent AEs and SAEs as assessed by vital signs
Time frame: 42 days (treatment period: 28 days, observation period: 14 days)
Measured as count of events.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRD001 in people with Healthy Volunteers, run by PRD Therapeutics, Inc. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent AEs and SAEs as assessed by vital signs (time frame: 42 days (treatment period: 28 days, observation period: 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.