NCT03955666

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Provention Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Safety

Interventions

Type	Name	Description
BIOLOGICAL	PRV-3279 or placebo	bi-specific antibody-based molecule

Timeline

• Start date: 2019-08-07
• Primary completion: 2019-12-11
• Completion: 2019-12-11
• First posted: 2019-05-20
• Last updated: 2023-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study