CompletedPhase 1ACTRN12624000967583

A Phase 1, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 Following Randomized, Double-blind, Placebo-controlled Single Ascending Doses in Healthy Subjects.

Sponsor

Parvus Therapeutics, Inc.

Enrollment

24 participants

Start Date

Oct 17, 2024

Study Type

Interventional

Conditions

Primary Biliary Cholangitis

Summary

The study Sponsor (Parvus Therapeutics) is developing a new drug called PVT201 for the treatment of Primary Biliary Cholangitis (PBC). This research study will examine the safety and tolerability of PVT201 for humans. This is a double-blind, randomized, placebo-controlled study where 4 dose levels of PVT201 will be evaluated in healthy volunteers. All participants will receive a single dose of PVT201 or Placebo on Day 1 of the study and participants will be followed up on Day 2 & Day 7 of the study.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria3

Healthy male or female, 18 to 65 years of age, inclusive with BMI between 18.0 to 32.0 kg/m2, inclusive
Carry the HLA DRB4*0101-allele
Medically healthy without clinically significant abnormalities based on physical examination, vital signs, ECG, and clinical laboratory tests

Exclusion Criteria9

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any hospitalisation or surgery within the past 4 weeks determined by an Investigator to be clinically relevant
Any active infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications
History of hypersensitivity reaction, anaphylaxis or other CS reactions or known allergy to the study drug or its ingredients including but not limited to dextran
Participant has undergone splenectomy or thymectomy
Use of an prescription medications within 14 days prior to the study drug administration or over-the-counter medications (excluding contraceptives), including herbal products and vitamins within 7 days prior to the study drug administration
Blood donation within 3 weeks prior to dose administration
Use of any vaccinations within 30 days prior to the study drug administration
Positive Hepatitis B surface antigen (HBsAg), Hepatitis C (HepC) virus antibody, or human immunodeficiency (HIV) antibody tests
History of drug or alcohol abuse

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Interventions

The study involves evaluating 4 dose levels of PVT201 - Cohort 1: 0.036 mg/kg; Cohort 2: 0.15 mg/kg; Cohort 3: 0.60 mg/kg; Cohort 4: 1.8 mg/kg All participants will receive a single dose of PVT201

The study involves evaluating 4 dose levels of PVT201 - Cohort 1: 0.036 mg/kg; Cohort 2: 0.15 mg/kg; Cohort 3: 0.60 mg/kg; Cohort 4: 1.8 mg/kg All participants will receive a single dose of PVT201 or placebo on Day 1 via intravenous infusion. Adherence to the intervention will be done via supervised drug administration.