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COMPLETEDPhase 1NCT03955666

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

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

Lead sponsor: Provention Bio, Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Provention Bio, Inc.

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.

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 28, 2023Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment16

Start dateAug 2019

Last updatedAug 28, 2023

Condition

Locations shown

Clinical site

Baltimore, Maryland

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2023Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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