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NCT07423000

PHASE1

A Phase 1 Study of PVT401 in Healthy Subjects

Sponsor: Parvus Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04

Completion Date

2027-11

Last Updated

2026-02-20

Healthy Volunteers

Yes

Conditions

Inflammatory Bowel Disease (IBD)

Interventions

DRUG

PVT401

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 recognized by the T-cell antigen receptor. PVT401 is a nanomedicine that will be used to target effector T-cells in patients with inflammatory bowel disease (IBD), converting them to Type 1 regulatory cells. IV delivery in nonclinical models of IBD induced immune tolerance and attenuation of disease pathology without impairing normal immunity to vaccines or viral and bacterial infections. PVT401 will be administered intravenously to healthy volunteers, first as a single dose and then as a multiple dose treatment regimen.

DRUG

Normal Saline (0.9% NaCl)

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.

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)

Nucleus Network Pty Ltd

Melbourne, Victoria, Australia