Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
Study NCT ID:
NCT03955666
Status:
COMPLETED
Last Update Posted:
2023-08-28
First Post:
2019-05-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects
Sponsor:
Provention Bio, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREVAIL1
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: