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

NCT03955666 | Completed Phase 1 FDA Drug

• 1 other identifier: PRV-3279-1b
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment-emergent adverse events (TEAEs)

  Assessment of safety and tolerability

  85 days

Study Arms (2)

Cohort A (PRV-3279 or placebo)

EXPERIMENTAL

Sterile solution for intravenous administration, 3 doses, every 2 weeks

Biological: PRV-3279 or placebo

Cohort B (PRV-3279 or placebo)

EXPERIMENTAL

Sterile solution for intravenous administration, 3 doses, every 2 weeks

Biological: PRV-3279 or placebo

Interventions

PRV-3279 or placebo BIOLOGICAL

bi-specific antibody-based molecule

Cohort A (PRV-3279 or placebo); Cohort B (PRV-3279 or placebo)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
• Body mass index (BMI) 18 to 32 kg/m2, inclusive.
• Male or female 18 to 50 years of age, inclusive.
• 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.

You may not qualify if:

• Women who are pregnant or breastfeeding.
• Evidence of active or chronic infections.
• Previous exposure to PRV-3279.
• 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.

Sponsors & Collaborators

• Provention Bio, Inc.: lead

Study Sites (1)

Clinical site

Baltimore, Maryland, 21225, United States

Location

Study Officials

• Chief Medical Officer

  Provention Bio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, multiple ascending dose study

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: August 7, 2019
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: August 28, 2023

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)