None listed
Conditions
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 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.
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 or placebo on Day 1 via intravenous infusion.
Adherence to the intervention will be done via supervised drug administration.
Sponsors
Parvus Therapeutics, Inc.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Outcome results
None listed