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

Phase 1

Completed

• Conditions: Safety
• Interventions: Biological: PRV-3279 or placebo

• Registration Number: NCT03955666
• Lead Sponsor: Provention Bio, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-20
• Study Start: 2019-08-07
• Status Verified: 2019-12
• Primary Completion: 2019-12-11
• Study Completion: 2019-12-11
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort A (PRV-3279 or placebo)	PRV-3279 or placebo	Sterile solution for intravenous administration, 3 doses, every 2 weeks
Cohort B (PRV-3279 or placebo)	PRV-3279 or placebo	Sterile solution for intravenous administration, 3 doses, every 2 weeks

Primary Outcome Measures

Name	Time	Method
Incidence and severity of treatment-emergent adverse events (TEAEs)	85 days	Assessment of safety and tolerability

Trial Locations

Locations (1)

Clinical site; 🇺🇸 Baltimore, Maryland, United States