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 primary biliary cholangitis/primary sclerosing cholangitis patients.

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 primary biliary cholangitis/primary sclerosing cholangitis patients

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625000683437

Enrollment

Registered

2025-06-27

Start date

2025-07-04

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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 registration is for the patient cohort, examining PVT201 in participants with PBC/PSC. All participants will receive a single dose of PVT201 on Day 1 of the study and participants will be followed-up on Day 2 & Day 7 of the study.

Interventions

This study is cohort 5 from the previous 4 cohorts registered in ACTRN12624000967583. The cohort in this section of the study (cohort 5) will evaluate 3.6mg/kg dose level of PVT201 (in-patient cohort). All participants in this cohort will receive a single dose of PVT201. The mode of administration is intravenous infusion. Adherence to the intervention will be done via supervised drug administration.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

- Male or female, 18 to 75 years of age, inclusive with BMI between 18.0 to 35.0 kg/m2, inclusive - Carry the HLA DRB4*0101 or DRB4*0103 -allele -Diagnosis of primary biliary cholangitis/primary sclerosing cholangitis - Medically fit for participation without clinically significant abnormalities based on vital signs, and ECG.

Exclusion criteria

- 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 (Hep C) virus antibody, or human immunodeficiency (HIV) antibody tests

Outcome results