Primary Biliary Cholangitis (PBC)Phase 1NCT06798454

Single Ascending Dose Study to Evaluate Safety Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 in Healthy Subjects and Patients (PBC/PSC)

A Phase 1 study testing PVT201 in people with Primary Biliary Cholangitis (PBC), run by Parvus Therapeutics, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The goal of this clinical trial is to learn what happens to PVT201 when it enters your body and how it affects your immune system. It will also learn about the safety of PVT201 after a single dose. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Primary Biliary Cholangitis (PBC)
What is being tested?: PVT201
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteAustralia
Study dates: 15 Oct 2024to 23 Apr 2025
Phase: Phase 1
Are there results?: None posted in the registry

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, with body weight ≥ 50.0 kg and < 120.0 kg.
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 CS abnormalities.
Female participants must be of non-child-bearing potential, or, if of child-bearing potential:
Must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test on Day -1.

Show all 25Show fewer

Must agree not to donate ova or attempt to become pregnant from the time of signing consent until at least 30 days after the dose of study drug.
If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception established at Screening until at least 30 days after the dose of study drug.
Male participants must:
Agree not to donate sperm from the time of signing consent until at least 90 days after the dose of study drug.
If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception from the time of signing consent until at least 90 days after the dose of study drug.
Male or female, aged between 18 and 75 years, inclusive at Screening.
Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive, with body weight ≥ 50.0 kg and < 120.0 kg.
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 CS abnormalities.
Male or female with a diagnosis of primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC).
For subjects on any medication used to treat the symptoms of PBC or PSC (examples: UDCA, OCA, seladelpar), subjects must be on a stable dose for a minimum of 2 months prior to Day 1 and expected to stay on treatment for duration of study participation OR must have been off treatment for at least 2 months prior to Day 1.
Subjects with inflammatory bowel disease (IBD) must have been on stable therapy > 2 months prior to Day 1.
Female participants must be of non-child-bearing potential, or, if of child-bearing potential:
Must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test on Day -1,
Must agree not to donate ova or attempt to become pregnant from the time of signing consent until at least 30 days after the dose of study drug,
If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception established at Screening until at least 30 days after the dose of study drug.
Male participants must:
Agree not to donate sperm from the time of signing consent until at least 90 days after the dose of study drug,
If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception from the time of signing consent until at least 90 days after the dose of study drug.

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 clinically significant 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.
Participant has undergone splenectomy or thymectomy.
Laboratory results at Screening that indicate inadequate renal function, with estimated creatinine clearance of < 60 mL/min/1.73m2.
Liver function test results elevated more than 1.5-fold above the upper limit of normal for GGT, ALP, AST or ALT.

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Total bilirubin > 1.5-fold above the upper limit of normal.
Use of any prescription medication within 14 days prior to the dose of study drug and/or over-the-counter medication/vitamins/supplements/herbal/plant-derived medications within 7 days prior to the dose of study drug.
Concurrent enrollment in another clinical study, or participation in another clinical study within 30 days prior to Screening.
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 has a positive cotinine test upon admission to the clinic on Day -1.
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.
Known substance abuse or medical, psychological, or social conditions that in the opinion of the study doctor would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
PBC/PSC PATIENT ELIGIBILITY CRITERIA
Current or a history of hepatic decompensation events.
Subject is diagnosed with Gilbert's Syndrome.
Subjects who have previously undergone liver transplantation.
History of ileectomy, colostomy, colectomy, splenectomy, or thymectomy.
Any active infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
Co-existing liver or biliary diseases, such as choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), hepatorenal syndrome, cholangiocarcinoma diagnosed or suspected liver cancers.
Presence of conditions that may cause non-hepatogenic ALP elevations (eg, Paget's disease) or conditions that may lead to a life expectancy of less than 2 years.
History of active malignancy within the past year except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
Positive Hepatitis B surface antigen (HBsAg), Hepatitis C (HepC) virus antibody, or human immunodeficiency (HIV) antibody tests.
Laboratory Screening Results:
AST >5 x ULN,
ALT >5 x ULN,
ALP > 10 x ULN,
Total bilirubin > 1.5 x ULN,
Albumin < 35 g/L,
Total white blood cells (WBC) <3000 cells/mm3,
Absolute neutrophil count (ANC) <1500 cells/mm3,
Platelet count <130,000/mm3, unless on stable anticoagulants at the discretion of the investigator,
Prothrombin time (international normalized ratio, INR) >1.3,
Serum creatinine >175 µmol/L or creatinine clearance <50 mL/min.
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.
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 has a positive cotinine test at Screening, upon admission to the clinic on Day -1.
Participant is breastfeeding/lactating or pregnant, or planning to breastfeed or become pregnant during the study.
Immunosuppressant therapies including methotrexate, azathioprine, or long-tern systemic corticosteroids within 2 months prior to Day 1.
Treatment with any other investigational therapy or device within 6 weeks or within 5 half-lives, whichever is longer, prior to Day 1.
Known substance abuse or medical, psychological, or social conditions other than PBC or PSC, or prior therapy that in the opinion of the PI would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Trial locations and contacts

1 site in 1 country.

Australia1 site

CMAX Clinical Research
Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: A Phase 1, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 Following Randomized, Double-blind, Placebo-controlled Single Ascending Doses in Healthy Subjects and Patients (PBC/PSC)

Will participants experience any side effects when taking PVT201? How long does it take PVT201 to leave your body after you take it?

Healthy volunteers will:

stay in the clinic for two nights, get one dose of PVT201 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 approximately one week after their dose for a final study visit.

Patients with primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC) will have the same procedures performed as healthy volunteers; however, none of the patients will receive placebo (all patients will be given PVT201).

Read the detailed description

This is a randomized, double-blind, placebo-controlled, single ascending dose, multi-cohort study conducted in healthy participants and patients with PBC/PSC.

Healthy adult participants will be enrolled to 1 of 4 main cohorts (Cohorts 1-4; 6 participants per cohort), and randomized to receive single ascending doses of PVT201 or placebo.

Dosing in each cohort begins with two sentinel subjects randomized such that one will receive PVT201 and the other will receive placebo (normal saline; 0.9% sodium chloride). The safety and tolerability of each sentinel participant will be monitored in the clinic until 24 hours post-dose. Following completion of Day 2 assessments for sentinel participants, all available safety/tolerability information will be reviewed prior to making the decision to dose the remaining participants in each cohort. Participants will be discharged after Day 2 assessments have been completed, and will return to the clinic for a final study visit on Day 7.

After the completion of each cohort, the decision to advance to the next dose cohort will be made by the Safety Review Committee (SRC) following review of safety and tolerability data of at least 4 of 6 participants, up to and including the Day 7 visit.

Cohorts will be dosed in an escalating order, unless otherwise indicated by the Safety Review Committee. At the discretion of the Sponsor and Safety Review Committee, healthy adult participants may be enrolled in up to one additional cohorts (6 participants per cohort) and randomized to receive single doses of PVT201 or placebo (ratio 2:1 active:placebo), to achieve the objectives of the study. If an additional cohort is required, it will commence with two sentinels, with one of the two sentinels randomized to receive PVT201 and the other randomized to receive placebo.

After completion of a minimum of 4 cohorts and with the approval of the SRC, the final cohort of the study will enroll up to 6 patients diagnosed with either PBC or PSC (of which at least half of the participants must have PBC). This cohort will not be blinded or placebo controlled, but will commence with one sentinel subject that will be monitored as noted above for previous cohorts prior to subsequent subject dosing. The dose level of the cohort will be the highest dose administered in the previous cohorts that was deemed safe and well tolerated by the SRC. All study visits and procedures noted for the healthy volunteer cohorts will also apply to the PBC/PSC patient cohort.

Conditions: Primary Biliary Cholangitis (PBC)
Being tested: PVT201, Placebo
Keywords: first-in-human, healthy volunteer, single ascending dose, PBC, PSC, randomized
Medical subject headings: Liver Cirrhosis, Biliary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PVT201Drug
Also called Navacim
Navacims are a novel class of nano-particle-based therapeutics being developed for the treatment of autoimmune diseases. A navacim consists 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.
PVT201 is a navacim that will be used to target human PDC-reactive effector T-cells in patients with primary biliary cholangitis (PBC), converting them to Type 1 regulatory cells.
IV delivery of navacims in nonclinical models of PBC induced immune tolerance and attenuation of disease pathology without impairing normal immunity to vaccines or viral and bacterial infections.
PVT201 will be administered intravenously.
PlaceboOther
Also called normal saline, 0.9% NaCl
Participants randomized to placebo will be administered normal saline IV.

Study groups in NCT06798454
Study group	Role	What they receive
PVT201	Experimental	PVT201 will be administered as a single IV dose. Planned doses are: Cohort 1 Healthy Volunteers: A mg/kg Cohort 2 Healthy Volunteers: B mg/kg Cohort 3 Healthy Volunteers: C mg/kg Cohort 4 Healthy Volunteers: D mg/kg Final Cohort PBC/PSC Patients: the highest dose that was deemed safe and well tolerated in the Healthy Volunteer cohorts Receives: Drug: PVT201
Placebo (normal saline, 0.9% sodium chloride)	Placebo comparator	All Healthy Volunteer cohorts will be administered either PVT201 or placebo in a ratio of 2:1 PVT201:placebo. Patient receiving placebo will be administered an equivalent volume of normal saline as a single IV dose. The PBC/PSC patients in the final cohort will not be administered placebo - all patients in this cohort will receive PVT201. Receives: Other: Placebo

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 IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Safety endpoints include incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) (including withdrawals due to AEs);
Measured: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Safety endpoints include change from baseline in vital signs (temperature measured in degrees Celsius)
Measured: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Safety endpoints include change from baseline in vital signs (heart rate measured in beats per minute)
Measured: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Safety endpoints include change from baseline in vital signs (blood pressure measured in mmHg)
Measured: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Safety endpoints include change from baseline in clinical laboratory parameters (hematology)
Measured: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Safety endpoints include change from baseline in clinical laboratory parameters (serum chemistry including liver function tests).
Measured: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Safety endpoints include change from baseline in clinical laboratory parameters (coagulation parameters).
Measured: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Safety endpoints include change from baseline in clinical laboratory parameters (urinalysis).
Measured: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: PR Interval (msec)
Measured: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: QRS Duration (msec)
Measured: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: QT Interval (msec)
Measured: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: QTcF (msec)
Measured: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)

Secondary outcomes (7)

To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Pharmacokinetic parameters to be evaluated include area under the concentration-time curve from 0 to time of last quantifiable concentration (AUClast).
Measured: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7
To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Pharmacokinetic parameters to be evaluated include maximum concentrations (Cmax).
Measured: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7
To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Pharmacokinetic parameters to be evaluated include time at which the maximum concentration is observed (tmax).
Measured: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7
To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Pharmacokinetic parameters to be evaluated include (but are not limited to) apparent terminal elimination half-life (t1/2).
Measured: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7
To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Pharmacokinetic parameters to be evaluated include (but are not limited to) total apparent body clearance (CL).
Measured: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7
To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Pharmacokinetic parameters to be evaluated include area under the concentration-time curve from 0 to infinity (AUCinf).
Measured: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7
To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Pharmacokinetic parameters to be evaluated include (but are not limited to) apparent volume of distribution (Vz).
Measured: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202423 Apr 2025

First posted29 Jan 2025
Study start15 Oct 2024
Primary completion23 Apr 2025
Study completion23 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary Biliary Cholangitis (PBC)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
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06798454
Sponsor's protocol ID: PVT201_C1_001
Status last verified: Nov 2025
First submitted: 8 Oct 2024
Last updated: 24 Nov 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2025. 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 PVT201 Following Randomized, Double-blind, Placebo-controlled Single Ascending Doses in Healthy Subjects and Patients (PBC/PSC)
ClinicalTrials.gov ID: NCT06798454
Acronym / sponsor ID: PVT201_C1_001
Conditions: Primary Biliary Cholangitis (PBC)
Keywords: first-in-human, healthy volunteer, single ascending dose, PBC, PSC, randomized
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Parvus Therapeutics, Inc.Industry (pharma, biotech, devices)
Collaborators: Avance Clinical Pty Ltd.
Study start: 15 Oct 2024 (actual)
Primary completion: 23 Apr 2025 (actual)
Study completion: 23 Apr 2025 (actual)
First posted: 29 Jan 2025 (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.

Will participants experience any side effects when taking PVT201? How long does it take PVT201 to leave your body after you take it?

Healthy volunteers will:

Detailed description

This is a randomized, double-blind, placebo-controlled, single ascending dose, multi-cohort study conducted in healthy participants and patients with PBC/PSC.

Healthy adult participants will be enrolled to 1 of 4 main cohorts (Cohorts 1-4; 6 participants per cohort), and randomized to receive single ascending doses of PVT201 or placebo.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PVT201	Experimental	Drug: PVT201PVT201 will be administered as a single IV dose. Planned doses are: Cohort 1 Healthy Volunteers: A mg/kg Cohort 2 Healthy Volunteers: B mg/kg Cohort 3 Healthy Volunteers: C mg/kg Cohort 4 Healthy Volunteers: D mg/kg Final Cohort PBC/PSC Patients: the highest dose that was deemed safe and well tolerated in the Healthy Volunteer cohorts
Placebo (normal saline, 0.9% sodium chloride)	Placebo comparator	Other: PlaceboAll Healthy Volunteer cohorts will be administered either PVT201 or placebo in a ratio of 2:1 PVT201:placebo. Patient receiving placebo will be administered an equivalent volume of normal saline as a single IV dose. The PBC/PSC patients in the final cohort will not be administered placebo - all patients in this cohort will receive PVT201.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (25 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, with body weight ≥ 50.0 kg and < 120.0 kg.
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 CS abnormalities.
Female participants must be of non-child-bearing potential, or, if of child-bearing potential:

Key exclusion criteria (44 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 clinically significant 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.
Participant has undergone splenectomy or thymectomy.
Laboratory results at Screening that indicate inadequate renal function, with estimated creatinine clearance of < 60 mL/min/1.73m2.

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
PVT201Also: NavacimNavacims are a novel class of nano-particle-based therapeutics being developed for the treatment of autoimmune diseases. A navacim consists 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. PVT201 is a navacim that will be used to target human PDC-reactive effector T-cells in patients with primary biliary cholangitis (PBC), converting them to Type 1 regulatory cells. IV delivery of navacims in nonclinical models of PBC induced immune tolerance and attenuation of disease pathology without impairing normal immunity to vaccines or viral and bacterial infections. PVT201 will be administered intravenously.	Drug	PVT201
PlaceboAlso: normal saline, 0.9% NaClParticipants randomized to placebo will be administered normal saline IV.	Other	Placebo (normal saline, 0.9% sodium chloride)

Primary outcome

To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Time frame: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
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 IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Time frame: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
Safety endpoints include change from baseline in vital signs (temperature measured in degrees Celsius)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Time frame: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
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 IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Time frame: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
Safety endpoints include change from baseline in vital signs (blood pressure measured in mmHg)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Time frame: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
Safety endpoints include change from baseline in clinical laboratory parameters (hematology)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Time frame: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
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 IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Time frame: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
Safety endpoints include change from baseline in clinical laboratory parameters (coagulation parameters).
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Time frame: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
Safety endpoints include change from baseline in clinical laboratory parameters (urinalysis).
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Time frame: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: PR Interval (msec)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Time frame: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: QRS Duration (msec)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Time frame: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: QT Interval (msec)
To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients.
Time frame: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)
Safety endpoints include change from baseline in electrocardiogram (ECG) parameters: QTcF (msec)

7 secondary outcomes

To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Time frame: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7
To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Time frame: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7
To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Time frame: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7
To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Time frame: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7
To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Time frame: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7
To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Time frame: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7
To measure the pharmacokinetics (PK) of PVT201 in plasma following a single IV dose in healthy participants and in PBC/PSC patients.
Time frame: Day 1: pre-dose and t= 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr; Day 2 = 24 hr; Day 7

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 PVT201 in people with Primary Biliary Cholangitis (PBC), 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 25 inclusion and 44 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: finished, as of the sponsor's last update on 24 Nov 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability of a single IV dose of PVT201 in healthy participants and in PBC/PSC patients. (time frame: To be measured at Baseline, Day 1, Day 2, and Day 7 (~7 days)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06798454.

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 24 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.