IBD (general)Recruiting

A Phase 1 Study of PVT401 in Healthy Subjects

Phase 1 · Testing PVT401 and Normal Saline (0.9% NaCl) · 1 site · Parvus Therapeutics, Inc.

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing PVT401 (a drug) and Normal Saline (0.9% NaCl) (a drug) as a possible treatment. Condition(s) listed: Inflammatory Bowel Disease (IBD).

Participants are assigned to groups by chance (randomized).

Some participants receive a placebo or sham for comparison.

It is blinded: participants and the study team do not know who receives what.

Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.

Who can join

Ages 18 to 65
Any sex
Healthy volunteers accepted

Some of the main requirements, copied from the record:

Healthy male or female, aged between 18 and 65 years, inclusive at Screening.
Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
Carry the HLA DRB4*0101 or DRB4*0103 allele.
Participant is medically healthy (in the opinion of the Investigator), as determined by pre-study medical history and without clinically significant (CS) abnormalities.
Female participants must be of non-child-bearing potential, or, if of child-bearing potential, must have negative pregnancy test, agree not to become pregnant or donate ova, and must agree to use adequate contraception.
Male participants must agree not to donate sperm and use adequate contraception.

There are also 18 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 36 participants are expected to take part.
The study has 4 groups.
Start date: 2026-04-13.
Main results expected around 2027-11 (estimate from the record).
1 study site listed (1 marked recruiting) in Australia.

Groups in this study

single dose PVT401 (listed as: experimental group)
single dose, normal saline (listed as: placebo group)
multiple doses, PVT401 (listed as: experimental group)
multiple doses, normal saline (listed as: placebo group)

Main thing being measured

To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: adverse and serious adverse events (From enrollment through 4-weeks post last dose of study drug)
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: vital signs (temperature) (From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose…)
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: vital signs (heart rate) (From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose…)

In the researchers’ words

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?

Words you might see

Placebo: a look-alike pill or injection with no active drug, used for comparison.

General definitions, not specific to this trial.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Phase 1
Study type	Interventional
Conditions	Inflammatory Bowel Disease (IBD)
Lead sponsor	Parvus Therapeutics, Inc.
Collaborators	Southern Star Research
Enrollment	36 (estimated)
Start date	2026-04-13
Primary completion (est.)	2027-11
First posted	2026-02-20
Last updated	2026-09-30
Official title	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
ClinicalTrials.gov ID	NCT07423000

Interventions

PVT401 (Drug)
Parvus pMHC nanomedicines are being developed for the treatment of autoimmune diseases. They consist of an iron oxide core surrounded by dextran that has been linked to multiple copies of a major histocompatibility complex Class II molecule and peptide. The peptide representing a disease-associated autoantigen and its paired MHC II molecule are specific to each autoimmune disease, and will be reco…
Normal Saline (0.9% NaCl) (Drug)
All cohorts will be administered either PVT401 or placebo in a ratio of 2:1 PVT401:placebo. Participants receiving placebo will be administered an equivalent volume of normal saline as either a single IV dose or as a multiple dose treatment regimen.

Full eligibility criteria (from the record)

Inclusion Criteria:

1. Healthy male or female, aged between 18 and 65 years, inclusive at Screening.
2. Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
3. Carry the HLA DRB4*0101 or DRB4*0103 allele.
4. Participant is medically healthy (in the opinion of the Investigator), as determined by pre-study medical history and without clinically significant (CS) abnormalities.
5. Female participants must be of non-child-bearing potential, or, if of child-bearing potential, must have negative pregnancy test, agree not to become pregnant or donate ova, and must agree to use adequate contraception.
6. Male participants must agree not to donate sperm and use adequate contraception.

Exclusion Criteria:

1. Any active infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
2. 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.
3. History of any CS disorder which, in the opinion of the Investigator would make implementation of the protocol or interpretation of study results difficult, or that would put the participant at risk by participating in the study.
4. History of surgery or hospitalisation within 4 weeks prior to Screening, or surgery planned during the study.
5. Participant has donated blood or blood products or experienced significant blood loss within 2 months prior to the first dose of study drug.
6. Use of any vaccinations within 4 weeks prior to the first dose of study drug.
7. Laboratory results at Screening that indicate inadequate renal function, with estimated creatinine clearance of < 60 mL/min/1.73m2.
8. Use of any prescription medication within 14 days prior to the first dose of study drug and/or over-the-counter medication/vitamins/supplements/herbal/ plant-derived medications within 7 days prior to the first dose of study drug.
9. Concurrent enrolment in another clinical study, or participation in another clinical study within 30 days or 5 half-lives, whichever is longer, prior to Screening.
10. Regular consumption of > 10 standard alcoholic drinks/week. Participant is unwilling to abstain from alcohol while confined to the study clinic.
11. Positive alcohol breath test at Screening, upon admission to the clinic on Day -1.
12. Positive urine drugs of abuse test at Screening, upon admission to the clinic on Day -1.
13. Participant is a heavy smoker, define as more than 2 cigarettes per day or 10 per week.
14. Participant is unwilling to abstain from smoking while confined to the study clinic.
15. Participant is breastfeeding/lactating or pregnant, or planning to breastfeed or become pregnant during the study.
16. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C (HepC) virus antibody, or human immunodeficiency (HIV) antibody tests.
17. Positive for tuberculosis (TB) disease or latent TB infection.
18. Ingestion of poppy seed-containing foods or beverages within 48 hours prior to first dose of study drug.

Locations (1)

Site	City	Country	Site status
Nucleus Network Pty Ltd	Melbourne, Victoria	Australia	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.