A Phase 1 Study of PVT401 in Healthy Subjects

NCT07423000 | Recruiting Phase 1 DMC

• 1 other identifier: PVT401_C1_001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

Phase 1; First-in-human; Single ascending dose; Multiple ascending dose; Healthy volunteers

Outcome Measures

Primary Outcomes (13)

• To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: adverse and serious adverse events

  Safety endpoints include incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) (including withdrawals due to AEs)

  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)

  Safety endpoints include change from baseline in vital signs (temperature measured in degrees Celsius)

  From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)

• To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: vital signs (heart rate)

  Safety endpoints include change from baseline in vital signs (heart rate measured in beats per minute)

  From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)

• To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: vital signs (blood pressure)

  Safety endpoints include change from baseline in vital signs (blood pressure measured in mmHg)

  From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)

• To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: clinical laboratory parameters (hematology panel)

  Safety endpoints include change from baseline in clinical laboratory parameters (hematology)

  From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)

• To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants.: clinical laboratory parameters (serum chemistry panel)

  Safety endpoints include change from baseline in clinical laboratory parameters (serum chemistry including liver function tests).

  From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)

• To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: clinical laboratory parameters (coagulation panel)

  Safety endpoints include change from baseline in clinical laboratory parameters (coagulation parameters).

  From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)

• To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: clinical laboratory parameters (urinalysis)

  Safety endpoints include change from baseline in clinical laboratory parameters (urinalysis).

  From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)

• To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: clinical laboratory parameters (serum iron panel)

  Safety endpoints include change from baseline in clinical laboratory parameters (serum iron panel)

  From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)

• To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: ECG (PR interval)

  Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: PR Interval (milliseconds)

  From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)

• To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: ECG (QRS duration)

  Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: QRS Duration (milliseconds)

  From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)

• To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: ECG (QT interval)

  Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: QT Interval (milliseconds)

  From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)

• To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: ECG (QTcF)

  Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: QTcF (milliseconds)

  From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)

Secondary Outcomes (5)

• To measure the PK of PVT401 in plasma following single and multiple IV doses in healthy volunteers.

  Single Dose Cohorts: multiple timepoints pre-dose to 24 hours post-dose Multiple Dose Cohorts: *First and Last Dose: multiple timepoints from pre-dose to 4 hours post-dose

• To measure the PK of PVT401 in plasma following single and multiple IV doses in healthy volunteers.

  Single Dose Cohorts: multiple timepoints pre-dose to 24 hours post-dose Multiple Dose Cohorts: *First and Last Dose: multiple timepoints from pre-dose to 4 hours post-dose

• To measure the PK of PVT401 in plasma following single and multiple IV doses in healthy volunteers.

  Single Dose Cohorts: multiple timepoints pre-dose to 24 hours post-dose Multiple Dose Cohorts: *First and Last Dose: multiple timepoints from pre-dose to 4 hours post-dose

• To measure the PK of PVT401 in plasma following single and multiple IV doses in healthy volunteers.

  Single Dose Cohorts: multiple timepoints pre-dose to 24 hours post-dose Multiple Dose Cohorts: *First and Last Dose: multiple timepoints from pre-dose to 4 hours post-dose

• To measure the PK of PVT401 in plasma following single and multiple IV doses in healthy volunteers.

  Single Dose Cohorts: multiple timepoints pre-dose to 24 hours post-dose Multiple Dose Cohorts: *First and Last Dose: multiple timepoints from pre-dose to 4 hours post-dose

Study Arms (4)

single dose PVT401

EXPERIMENTAL

PVT401 will be administered as a single intravenous dose to healthy volunteers. There are a minimum of four cohorts planned, with the dose escalating in each subsequent cohort.

Drug: PVT401

single dose, normal saline

PLACEBO COMPARATOR

Participants receiving placebo will be administered a single intravenous dose of normal saline at an equivalent volume to a single IV PVT401 dose (mg/kg).

Drug: Normal Saline (0.9% NaCl)

multiple doses, PVT401

EXPERIMENTAL

Following completion of single-dose cohorts, PVT401 will be administered as a multiple intravenous dose treatment regimen to healthy volunteers. There are two cohorts planned, with the dose escalating in each subsequent cohort.

Drug: PVT401

multiple doses, normal saline

PLACEBO COMPARATOR

Participants receiving placebo will be administered multiple intravenous doses of normal saline at an equivalent volume to the IV PVT401 dose (mg/kg).

Drug: Normal Saline (0.9% NaCl)

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 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.

Also known as: Parvus pMHC nanomedicine

multiple doses, PVT401; single dose PVT401

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.

Also known as: placebo

multiple doses, normal saline; single dose, normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• History of surgery or hospitalisation within 4 weeks prior to Screening, or surgery planned during the study.
• Participant has donated blood or blood products or experienced significant blood loss within 2 months prior to the first dose of study drug.
• Use of any vaccinations within 4 weeks prior to the first dose of study drug.
• Laboratory results at Screening that indicate inadequate renal function, with estimated creatinine clearance of \< 60 mL/min/1.73m2.
• 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.
• 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.
• Regular consumption of \> 10 standard alcoholic drinks/week. Participant is unwilling to abstain from alcohol while confined to the study clinic.
• Positive alcohol breath test at Screening, upon admission to the clinic on Day -1.
• Positive urine drugs of abuse test at Screening, upon admission to the clinic on Day -1.
• Participant is a heavy smoker, define as more than 2 cigarettes per day or 10 per week.
• Participant is unwilling to abstain from smoking while confined to the study clinic.
• Participant is breastfeeding/lactating or pregnant, or planning to breastfeed or become pregnant during the study.

Sponsors & Collaborators

• Parvus Therapeutics, Inc.: lead
• Southern Star Research: collaborator

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Sarah Executive Director, Clinical Operations

CONTACT

+1 949 378 0896; sgrimberg@parvustx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study in healthy volunteers

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

AU (1)