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

Phase 1

• Conditions: Primary Biliary Cholangitis; Inflammatory and Immune System - Autoimmune diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12624000967583
• Lead Sponsor: Parvus Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-08
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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 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 (HepC) virus antibody, or human immunodeficiency (HIV) antibody tests
- History of drug or alcohol abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified