PVT401 in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nucleus Network Pty Ltd
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Sarah Executive Director, Clinical Operations
• Email: sgrimberg@parvustx.com
• Phone: +1 949 378 0896

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DISC-0974-201 for adults with IBD-related anemia

  This Phase 2 trial will test whether DISC-0974-201 helps adults with inflammatory bowel disease who have anemia driven by inflammation.

  Recruiting at 15 sites Phase 2 Disc Medicine, Inc · Birmingham, Alabama and 14 other locations · NCT07368972

• Moderate breathing and movement: Can regular exercise help people with quiescent inflammatory bowel disease feel better?

  This trial tests whether a moderate-intensity exercise program improves quality of life for adults with Crohn's disease or ulcerative colitis who are currently in clinical remission.

  Recruiting Mahidol University · Bangkok Noi, Bangkok · NCT07775794

• Mediterranean Diet and Time-Restricted Feeding in Ulcerative Colitis in Remission

  This study tests whether a Mediterranean diet, with or without an 8-hour eating window, helps gut health and quality of life in adults with ulcerative colitis in remission.

  Recruiting Pontificia Universidad Catolica de Chile · Santiago, Santiago Metropolitan · NCT07752446

• Screening for lipid disorders in children and teens with chronic diseases to flag cardiovascular risk

  This study tests a blood test and a questionnaire to screen children and teens with chronic conditions for lipid metabolism disorders and familial hyperlipidemia.

  Recruiting Jena University Hospital · Jena · NCT07716488

• Wearable data to spot IBD flareups in people with ulcerative colitis or Crohn's disease

  This study tests whether heart‑rate variability from participants’ own wearables can help predict IBD flares.

  Recruiting at 2 sites Maastricht University Medical Center · 's-Hertogenbosch and 2 other locations · NCT07647640

• Dexamethasone before infliximab for moderate-to-severe Crohn's disease and ulcerative colitis

  This project will test whether giving an IV dose of dexamethasone before infliximab infusions prevents allergic reactions in people aged 14–80 with moderate-to-severe Crohn's disease or ulcerative colitis.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07385131

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.