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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
PVT401
DrugParvus 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)
DrugAll 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.
Treatment groups
36 Participants
are divided into 4 treatment groupsGroup A: single dose PVT401Experimental treatment 1 intervention
Group B: single dose, normal salinePlacebo comparator 1 intervention
Group C: multiple doses, PVT401Experimental treatment 1 intervention
Group D: multiple doses, normal salinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
From enrollment through 4-weeks post last dose of study drug2
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)
Time frame
From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)3
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)
Time frame
From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)4
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)
Time frame
From enrollment through 4 weeks after dosing (single dose cohorts) or 6 months after the final dose (multiple dose cohorts)Secondary outcomes
1
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)
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-dose2
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)
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-dose3
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);
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-dose4
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);
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-doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Parvus Therapeutics, Inc.
Lead sponsor
Southern Star Research
Collaborator
Source ClinicalTrials.gov