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A phase 1 study of PRD001 in healthy participants: Part 1A - randomized, double-blind, placebo-controlled assessment of safety, tolerability and pharmacokinetics of single, ascending, oral doses with additional cohorts of Part 1B - effect of food on the pharmacokinetics of PRD001; Part 2A - randomized, double-blind, placebo-controlled assessment of safety, tolerability and pharmacokinetics of multiple, ascending, oral doses with expansion cohort of Part 2B - randomized, double-blind, placebo-controlled assessment of safety, pharmacodynamics and pharmacokinetics of multiple, oral doses in participants with borderline/mild hyper-LDL-cholesterolemia and mild fatty liver.

A First-in-Human study of PRD001 in healthy participants, assessment of safety, tolerability and pharmacokinetics of single/multiple doses

Hosoda Kanji

PRD Therapeutics Inc.

5-9-1 Shirokane Minato-ku, Tokyo

hosodak@prdtherapeutics.com

Hosoda Kanji

PRD Therapeutics Inc.

5-9-1 Shirokane Minato-ku, Tokyo

+81-80-9642-4922

hosodak@prdtherapeutics.com

Recruiting

June. 19, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

Part 1A, Part 1A' and Part 2A
1. Healthy men aged between 18 and 45 years inclusive at the time of signing the informed consent form (ICF),
Only Part 1A': Healthy men aged between 18 and 65 years inclusive at the time of signing the ICF or, healthy women of non-childbearing potential aged between 18 and 65 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 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 (temperature, blood pressure, pulse rate, and respiratory rate), 12-lead ECG, and laboratory test results at screening.
5. For Japanese participants in Part 1A, 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.
If participating from Part 1B, individuals who meet the inclusion criteria for Part 1A.

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 based on medical history, physical examinations, vital signs, 12-lead ECG, and laboratory test results at screening. However, the following individuals are permitted.
i. Individuals managed solely with diet therapy or exercise therapy
ii. Individuals whose aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are within 1.5 times of the upper limit of the normal range.
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

All parts
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.

Both

Homozygous-Familial Hypercholesterolemia

Part 1A: PRD001 or placebo will be administered orally after an overnight fast.
Part 1B: PRD001 will be administered orally within 30 minutes after a regular meal.
Part 1A': PRD001 will be administered orally within 30 minutes after a high-fat meal.
Part 2A and Part 2B: PRD001 or placebo will be administered orally within 2 hours after meals.

Safety and tolerability based on the following evaluations:
- Treatment-emergent adverse events
- Serious adverse events
- Vital signs
- Laboratory test results
- 12-lead ECG

Plasma PRD001 concentrations and the PK parameters

+81-92-283-7701

May. 09, 2025

No

none