A Phase 1 Study of PVT401 in Healthy Subjects

ConditionInflammatory Bowel Disease (IBD)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorParvus Therapeutics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

PVT401
Normal Saline (0.9% NaCl)

Treatment groups

36 Participants

are divided into 4 treatment groups

Sponsors and collaborators

Parvus Therapeutics, Inc.

Lead sponsor

Southern Star Research

Collaborator

Source ClinicalTrials.gov