A Phase 1 interventional study of PVT401 and Normal Saline (0.9% NaCl) in Inflammatory Bowel Disease (IBD), sponsored by Parvus Therapeutics, Inc.. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Parvus Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
SAD Phase: four cohorts are planned (n=6 per cohort; 2:1 randomization of PVT401 to placebo). This phase consists of five study visits: Screening, Treatment, and Follow-up (Day 8, Day 15, and Day 29). The Screening and Follow-up visits are outpatient; the Treatment visit includes a two-night inpatient stay from Day -1 to Day 2.
Participants will be admitted to the clinic on Day -1, the day prior to dosing. PK sampling will take place on Day 1, and the safety and tolerability of the study drug will be monitored for each participant in the clinic until Day 2 (24 hours post-dose) checkout.
The decision to advance to the subsequent SAD dose cohort will be made by a Safety Review Committee (SRC) following review of all available safety and tolerability data of participants through Day 8.
After completion of a minimum of four cohorts and with the approval of the SRC, the study will transition to the MAD phase.
MAD Phase: two cohorts are planned (n=6 per cohort; 2:1 randomization of PVT401 to placebo). This phase consists of 15 study visits: Screening: Visit 1, Treatment (Visits 2 - 11, dosing b.i.w. for 5 weeks), and Follow-up (Visits 12 - 15, up to 6 months post-dose).
All Treatment visits include a one-night inpatient stay prior to dosing; the Screening and Follow-up visits are outpatient.
The Screening visit can take place up to 42 days prior to Day 1. Participants will check in to the clinic on Day -1, the day prior to the first planned dose on Day 1. Dosing in each cohort will commence with two sentinel participants randomized such that one will receive PVT401 and the other will receive placebo (normal saline; 0.9% sodium chloride). The safety and tolerability of the study drug will be monitored for each sentinel participant through the first two doses (Week 1, Day 1 and Day 4) and will be reviewed by the Investigator prior to dosing the remainder of the participants in the cohort. Following completion of the Day 4 assessments for sentinel participants, all available safety/tolerability information will be reviewed by the Investigator prior to making the decision to dose the remaining participants in each cohort. Once safety and tolerability have been confirmed, the remaining four participants will be randomised (3:1 ratio of PVT401:placebo).
On Week 1, Day 1, all participants will remain for 8 hours after their first dose for observation and PK sampling prior to discharge. Participants will also remain for assessments and observation for a minimum of 8 hours post-dose at all other dosing visits.
The decision to advance to the next MAD dose cohort will be made by the SRC after completion of the five-week dosing cycle, following review of all available safety and tolerability data from the previous cohorts.
1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.
This study's planned enrollment of 36 is below the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Parvus Therapeutics, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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)
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
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)
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
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
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)
To measure the PK of PVT401 in plasma following single and multiple IV doses in healthy volunteers.
PK parameters to be evaluated include area under the concentration-time curve from 0 to time of last quantifiable concentration (AUClast)
Time frame: 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.
PK parameters to be evaluated include area under the concentration-time curve from 0 to infinity (AUCinf)
Time frame: 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.
PK parameters to be evaluated include maximum concentrations (Cmax);
Time frame: 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.
PK parameters to be evaluated include time at which the maximum concentration is observed (tmax);
Time frame: 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.
PK parameters to be evaluated include apparent terminal elimination half-life (t1/2)
Time frame: 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
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Parvus Therapeutics, Inc.