PVT401 in healthy adults

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

This trial will test intravenous PVT401 in healthy adults who carry the HLA DRB4*0101 or DRB4*0103 allele to see how the drug behaves in the body and whether single and multiple doses are safe.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Parvus Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT07423000 on ClinicalTrials.gov

What this trial studies

This first-in-human, phase 1 trial enrolls healthy volunteers to characterize the pharmacokinetics and safety of intravenous PVT401. The single ascending dose (SAD) phase includes four cohorts of six participants each randomized 2:1 to drug or placebo with a two-night inpatient stay and serial blood sampling. After safety review, the study moves to a multiple ascending dose (MAD) phase with two cohorts dosed twice weekly over five weeks, each dosing preceded by a one-night inpatient stay and longer follow-up. A Safety Review Committee will review tolerability data (through Day 8 in SAD) before escalating doses or proceeding to the MAD phase.

Who should consider this trial

Good fit: Healthy adults aged 18–65 with BMI 18–32 kg/m2 who carry HLA DRB4*0101 or DRB4*0103, are medically well by exam/history, and agree to the contraception and donation restrictions are ideal candidates.

Not a fit: People with active infections, a history of severe hypersensitivity to similar agents, those who do not carry the required HLA alleles, or who are medically unstable are unlikely to benefit from participation.

Why it matters

Potential benefit: If PVT401 is safe and shows the expected immune effects, it could support development of a new therapy pathway for people with inflammatory bowel disease.

How similar studies have performed: This is a first-in-human trial of PVT401; while other immune-targeting therapies for IBD have had success in later-phase trials, PVT401 itself has not been tested in humans before.

Eligibility criteria

Inclusion Criteria:

1. Healthy male or female, aged between 18 and 65 years, inclusive at Screening.
2. Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
3. Carry the HLA DRB4\*0101 or DRB4\*0103 allele.
4. Participant is medically healthy (in the opinion of the Investigator), as determined by pre-study medical history and without clinically significant (CS) abnormalities.
5. Female participants must be of non-child-bearing potential, or, if of child-bearing potential, must have negative pregnancy test, agree not to become pregnant or donate ova, and must agree to use adequate contraception.
6. Male participants must agree not to donate sperm and use adequate contraception.

Exclusion Criteria:

1. Any active infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
2. History of hypersensitivity reaction, anaphylaxis or other CS reactions or known allergy to the study drug or its ingredients including but not limited to dextran.
3. History of any CS disorder which, in the opinion of the Investigator would make implementation of the protocol or interpretation of study results difficult, or that would put the participant at risk by participating in the study.
4. History of surgery or hospitalisation within 4 weeks prior to Screening, or surgery planned during the study.
5. Participant has donated blood or blood products or experienced significant blood loss within 2 months prior to the first dose of study drug.
6. Use of any vaccinations within 4 weeks prior to the first dose of study drug.
7. Laboratory results at Screening that indicate inadequate renal function, with estimated creatinine clearance of \< 60 mL/min/1.73m2.
8. Use of any prescription medication within 14 days prior to the first dose of study drug and/or over-the-counter medication/vitamins/supplements/herbal/ plant-derived medications within 7 days prior to the first dose of study drug.
9. Concurrent enrolment in another clinical study, or participation in another clinical study within 30 days or 5 half-lives, whichever is longer, prior to Screening.
10. Regular consumption of \> 10 standard alcoholic drinks/week. Participant is unwilling to abstain from alcohol while confined to the study clinic.
11. Positive alcohol breath test at Screening, upon admission to the clinic on Day -1.
12. Positive urine drugs of abuse test at Screening, upon admission to the clinic on Day -1.
13. Participant is a heavy smoker, define as more than 2 cigarettes per day or 10 per week.
14. Participant is unwilling to abstain from smoking while confined to the study clinic.
15. Participant is breastfeeding/lactating or pregnant, or planning to breastfeed or become pregnant during the study.
16. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C (HepC) virus antibody, or human immunodeficiency (HIV) antibody tests.
17. Positive for tuberculosis (TB) disease or latent TB infection.
18. Ingestion of poppy seed-containing foods or beverages within 48 hours prior to first dose of study drug.

Where this trial is running

Melbourne, Victoria

• Nucleus Network Pty Ltd — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Sarah Executive Director, Clinical Operations

Conditions Inflammatory Bowel Disease; Phase 1; First-in-human; Single ascending dose; Multiple ascending dose; Healthy volunteers