Actively Recruiting
A Phase 1, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT401 Following Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Doses in Healthy Subjects
Led by Parvus Therapeutics, Inc. · Updated on 2026-04-13
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Parvus Therapeutics, Inc.
Lead Sponsor
S
Southern Star Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how PVT401, a drug designed for inflammatory bowel disease (IBD), behaves in the body and affects the immune system. This Phase 1 trial mainly focuses on understanding the safety and side effects of single and multiple intravenous doses of PVT401 in healthy adults aged 18 to 65. The study aims to find out how long the drug stays in the body and if any adverse events occur. The trial includes two phases: a Single Ascending Dose (SAD) phase and a Multiple Ascending Dose (MAD) phase. In the SAD phase, participants stay in the clinic for two nights, receive one intravenous dose of either PVT401 or placebo, and have blood samples taken over several visits up to four weeks after dosing. In the MAD phase, participants receive doses twice weekly for five weeks, staying overnight at the clinic before each dose, with follow-up visits extending up to six months after the last dose. Placebo groups receive normal saline matching the PVT401 dosing schedule. Participants will undergo various assessments including blood draws, vital sign monitoring, and safety evaluations during and after dosing. Researchers will measure laboratory parameters, electrocardiograms, and pharmacokinetics to evaluate the drug’s safety and how it is processed in the body. The study involves regular clinic visits for treatment and follow-up to monitor any side effects and ensure participant safety throughout the trial period.
CONDITIONS
Brief Title
A Phase 1 Study of PVT401 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males or females aged 18 to 65 years inclusive at screening
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive
- Carry the HLA DRB40101 or DRB40103 allele
- Medically healthy with no clinically significant abnormalities
- Females must be non-child-bearing or use effective contraception with negative pregnancy test
- Males must agree to use adequate contraception and not donate sperm
You will not qualify if you...
- Active infections needing systemic antibiotic, antifungal, antiparasitic, or antiviral treatment
- History of severe allergic reactions or allergy to study drug or its components including dextran
- Significant disorders that could affect study participation or safety
- Recent surgery or hospitalization within 4 weeks before screening or planned surgery during the study
- Blood donation or significant blood loss within 2 months before first dose
- Vaccination within 4 weeks before first dose
- Poor kidney function with creatinine clearance below 60 mL/min/1.73m2
- Use of prescription medication within 14 days or supplements/herbal products within 7 days before first dose
- Participation in another clinical trial within 30 days or 5 half-lives before screening
- Regular intake of more than 10 alcoholic drinks per week and unwillingness to abstain while in clinic
- Positive alcohol or drug tests at screening or clinic admission
- Heavy smoking defined as more than 2 cigarettes per day or 10 per week and unwillingness to abstain in clinic
- Breastfeeding or pregnant women or planning pregnancy during study
- Positive tests for hepatitis B, hepatitis C, HIV, or tuberculosis
- Consumption of poppy seed products within 48 hours before first dose of study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 weeks prior to dosing
Participants are screened for eligibility to participate in the trial.
1 outpatient visit
Duration - Single Dose Cohorts: 3 days (Day -1 to Day 2); Multiple Dose Cohorts: 5 weeks of dosing with twice-weekly visits
Participants receive either a single or multiple intravenous doses of the study drug or placebo. The treatment includes inpatient stays for monitoring and dosing over several days or weeks depending on the cohort.
Single Dose Cohorts: 1 inpatient stay of 2 nights; Multiple Dose Cohorts: Twice-weekly inpatient stays for 10 dosing visits
Duration - Single Dose Cohorts: up to 3 weeks; Multiple Dose Cohorts: up to 6 months
Participants are monitored for safety and tolerability after dosing, including outpatient visits for assessments up to 6 months post final dose in multiple dose cohorts.
Single Dose Cohorts: 3 outpatient visits; Multiple Dose Cohorts: 4 outpatient visits
Trial Site Locations
Total: 1 location
1
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
S
Sarah Executive Director, Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here