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

Safety Clinical Trial

— PREVAIL1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955666
• Other study ID #: PRV-3279-1b
• Status: Completed
• Phase: Phase 1
• Start date: August 7, 2019
• Est. completion date: December 11, 2019

Study information

• Verified date: December 2019
• Source: Provention Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 11, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Safety

Intervention

Biological:
• PRV-3279 or placebo
bi-specific antibody-based molecule

Locations

Country	Name	City	State
United States	Clinical site	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Provention Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of treatment-emergent adverse events (TEAEs)	Assessment of safety and tolerability	85 days