Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03955666
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03955666
Recruitment Status : Completed
First Posted : May 20, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Provention Bio, Inc.

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

Condition or disease Intervention/treatment Phase
Safety Biological: PRV-3279 or placebo Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Double-blind, placebo-controlled, multiple ascending dose study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 7, 2019
Actual Primary Completion Date : December 11, 2019
Actual Study Completion Date : December 11, 2019

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




Primary Outcome Measures :
  1. Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: 85 days ]
    Assessment of safety and tolerability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955666


Locations
Layout table for location information
United States, Maryland
Clinical site
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Provention Bio, Inc.
Investigators
Layout table for investigator information
Study Director: Chief Medical Officer Provention Bio, Inc.
Layout table for additonal information
Responsible Party: Provention Bio, Inc.
ClinicalTrials.gov Identifier: NCT03955666    
Other Study ID Numbers: PRV-3279-1b
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No