Actively Recruiting
A Phase 1 Study of PVT401 in Healthy Subjects
Led by Parvus Therapeutics, Inc. · Updated on 2026-04-13
36
Participants Needed
1
Research Sites
82 weeks
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
The goal of this clinical trial is to learn what happens to PVT401 when it enters the human body and how it affects the immune system. It will also provide information about the safety of PVT401 after a single dose and after multiple doses. The main questions it aims to answer are: Will participants experience any side effects when taking PVT401? How long does it take PVT401 to leave the body after it is administered? Healthy volunteers will participate in either the single ascending dose (SAD) or multiple ascending dose (MAD) phase. In the SAD phase, participants will: stay in the clinic for two nights, get one dose of PVT401 or a placebo intravenously (through a vein) on Day 1, have blood drawn periodically throughout their stay and be monitored for side effects, and return to the clinic for 3 follow up visits over the four weeks after dosing. In the MAD phase, participants will: stay in the clinic for one night prior to each dose of PVT401 or placebo, and get dosed twice a week for 5 weeks. They will have blood drawn periodically throughout the treatment period and be monitored for side effects, and return to the clinic for 4 follow up visits over the six months after dosing.
CONDITIONS
Official 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 at screening
- Body mass index (BMI) between 18.0 and 32.0 kg/m2
- Possess the HLA DRB40101 or DRB40103 allele
- Medically healthy with no clinically significant abnormalities
- Female participants must be non-child-bearing or have a negative pregnancy test, agree not to become pregnant or donate ova, and use adequate contraception
- Male participants must agree not to donate sperm and use adequate contraception
You will not qualify if you...
- Active infection requiring systemic antibiotic, antifungal, antiparasitic, or antiviral treatment
- History of severe allergic reactions or known allergy to the study drug or its ingredients including dextran
- History of any clinically significant disorder that may affect study participation or results
- Surgery or hospitalization within 4 weeks prior to screening or planned surgery during the study
- Blood donation or significant blood loss within 2 months prior to first dose
- Vaccination within 4 weeks prior to first dose
- Screening lab results showing inadequate kidney function (creatinine clearance < 60 mL/min/1.73m2)
- Use of prescription medication within 14 days or over-the-counter/vitamins/herbal supplements within 7 days prior to first dose
- Concurrent participation in another clinical study or recent participation within 30 days or 5 half-lives
- Regular consumption of more than 10 alcoholic drinks per week and unwillingness to abstain during clinic stay
- Positive alcohol breath or urine drug test at screening or admission
- Heavy smoking defined as more than 2 cigarettes per day or 10 per week and unwillingness to abstain during clinic stay
- Breastfeeding, pregnant, or planning pregnancy during the study
- Positive tests for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
- Positive for tuberculosis disease or latent TB infection
- Consumption of poppy seed foods or beverages within 48 hours prior to first dose of study drug
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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