A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects (PREVAIL1)

PREVAIL 1: A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects

This Phase 1b study will evaluate the safety of PRV-3279 in healthy adult subjects

Study Overview

• Status: Completed
• Conditions: Safety
• Intervention / Treatment: Biological: PRV-3279 or placebo

Detailed Description

PRV-3279-1b is a Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects.

Eligible subjects include healthy male or female adults, 18 to 50 years of age. Each subject will receive the assigned treatment over 29 days followed by a 56-day follow-up period.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
2. Body mass index (BMI) 18 to 32 kg/m2, inclusive.
3. Male or female 18 to 50 years of age, inclusive.
4. Nonpregnant women of childbearing potential (WOCBP) and sexually active men must agree to use effective birth control with male contraception during study participation through at least 3 months after the final dose. Women of non-childbearing potential may participate.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. Evidence of active or chronic infections.
3. Previous exposure to PRV-3279.
4. Any reason that, in the opinion of the Investigator, would contraindicate the subject's participation in the study or confound the results of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A (PRV-3279 or placebo); Sterile solution for intravenous administration, 3 doses, every 2 weeks	Biological: PRV-3279 or placebo; bi-specific antibody-based molecule
Experimental: Cohort B (PRV-3279 or placebo); Sterile solution for intravenous administration, 3 doses, every 2 weeks	Biological: PRV-3279 or placebo; bi-specific antibody-based molecule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs)	Assessment of safety and tolerability	85 days

Collaborators and Investigators

• Sponsor: Provention Bio, Inc.
• Investigators: Study Director: Chief Medical Officer, Provention Bio, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2019
• Primary Completion (Actual): December 11, 2019
• Study Completion (Actual): December 11, 2019

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PRV-3279-1b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No