A First-in-Human Study of PRD001

PRD Therapeutics, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: PRD001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07034183

PRD001-101-J

Details and patient eligibility

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.

Enrollment: 86 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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)
  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:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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86 participants in 4 patient groups

Part 1A: Single Ascending Dose

Experimental group

Treatment:

Drug: PRD001

Drug: Placebo

Part 1B: Dietary effects

Experimental group

Treatment:

Drug: PRD001

Part 2A: 14 days Multiple Ascending Dose

Experimental group

Treatment:

Drug: PRD001

Drug: Placebo

Part 2B: 28 days Multiple Ascending Dose

Experimental group

Treatment:

Drug: PRD001

Drug: Placebo