Inflammatory Bowel Disease (IBD)Phase 1NCT07423000
A Phase 1 Study of PVT401 in Healthy Subjects
A Phase 1 study testing PVT401 and Normal Saline (0.9% NaCl) in people with Inflammatory Bowel Disease (IBD), run by Parvus Therapeutics, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- PVT401 and Normal Saline (0.9% NaCl)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Apr 2026to Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- Positive Hepatitis B surface antigen (HBsAg), Hepatitis C (HepC) virus antibody, or human immunodeficiency (HIV) antibody tests.
- Positive for tuberculosis (TB) disease or latent TB infection.
- Ingestion of poppy seed-containing foods or beverages within 48 hours prior to first dose of study drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
Research Coordinator, 61 1800 423 733, melbourne@nucleusnetwork.com
About this study
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
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- PVT401, Normal Saline (0.9% NaCl)
- Keywords
- Phase 1, First-in-human, Single ascending dose, Multiple ascending dose, Healthy volunteers
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVT401Drug
Also called Parvus pMHC nanomedicine
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.
Normal Saline (0.9% NaCl)Drug
Also called placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: 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). Receives: Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
PK parameters to be evaluated include area under the concentration-time curve from 0 to time of last quantifiable concentration (AUClast)
Measured: 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)
Measured: 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);
Measured: 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);
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start13 Apr 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study in healthy volunteers
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parvus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Southern Star Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423000
- Sponsor's protocol ID
- PVT401_C1_001
- Status last verified
- Sep 2026
- First submitted
- 9 Feb 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- PVT401_C1_001
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- Phase 1, First-in-human, Single ascending dose, Multiple ascending dose, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Parvus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Southern Star Research
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study in healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| single dose PVT401 | Experimental | Drug: PVT401PVT401 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. |
| single dose, normal saline | Placebo comparator | Drug: Normal Saline (0.9% NaCl)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). |
| multiple doses, PVT401 | Experimental | Drug: PVT401Following 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. |
| multiple doses, normal saline | Placebo comparator | Drug: Normal Saline (0.9% NaCl)Participants receiving placebo will be administered multiple intravenous doses of normal saline at an equivalent volume to the IV PVT401 dose (mg/kg). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVT401Also: Parvus pMHC nanomedicineParvus 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 | multiple doses, PVT401, single dose PVT401 |
| Normal Saline (0.9% NaCl)Also: placeboAll 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. | Drug | multiple doses, normal saline, single dose, normal saline |
Primary outcome
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: adverse and serious adverse events
Time frame: From enrollment through 4-weeks post last dose of study drug
Safety endpoints include incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) (including withdrawals due to AEs)
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: vital signs (temperature)
Time frame: From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)
Safety endpoints include change from baseline in vital signs (temperature measured in degrees Celsius)
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: vital signs (heart rate)
Time frame: From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)
Safety endpoints include change from baseline in vital signs (heart rate measured in beats per minute)
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: vital signs (blood pressure)
Time frame: From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)
Safety endpoints include change from baseline in vital signs (blood pressure measured in mmHg)
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: clinical laboratory parameters (hematology panel)
Time frame: From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)
Safety endpoints include change from baseline in clinical laboratory parameters (hematology)
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants.: clinical laboratory parameters (serum chemistry panel)
Time frame: From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)
Safety endpoints include change from baseline in clinical laboratory parameters (serum chemistry including liver function tests).
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: clinical laboratory parameters (coagulation panel)
Time frame: From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)
Safety endpoints include change from baseline in clinical laboratory parameters (coagulation parameters).
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: 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)
Safety endpoints include change from baseline in clinical laboratory parameters (urinalysis).
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: 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)
Safety endpoints include change from baseline in clinical laboratory parameters (serum iron panel)
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: ECG (PR interval)
Time frame: From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)
Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: PR Interval (milliseconds)
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: ECG (QRS duration)
Time frame: From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)
Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: QRS Duration (milliseconds)
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: ECG (QT interval)
Time frame: From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)
Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: QT Interval (milliseconds)
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: ECG (QTcF)
Time frame: From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)
Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: QTcF (milliseconds)
5 secondary outcomes
To measure the PK of PVT401 in plasma following single and multiple IV doses in healthy volunteers.
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.
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.
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PVT401 and Normal Saline (0.9% NaCl) in people with Inflammatory Bowel Disease (IBD), run by Parvus Therapeutics, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Executive Director, Clinical Operations (+1 949 378 0896, sgrimberg@parvustx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of a single and multiple IV doses of PVT401 in healthy participants: adverse and serious adverse events (time frame: From enrollment through 4-weeks post last dose of study drug). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.