Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04690426
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2020-12-15
Brief Title:
PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers
Sponsor:
Provention Bio Inc
Organization:
Provention Bio Inc
Study Overview
Official Title:
A Phase 1 First-in-Human Randomized Double-Blind Placebo-Controlled Multiple-Dose-Escalation Study to Evaluate the Safety Tolerability and Immunogenicity of PRV-101 a Coxsackie Virus B CVB Vaccine in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2022-07
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:
PROVENT
Brief Summary:
Phase 1 first-in-human randomized double-blind placebo-controlled multiple-dose-escalation study to evaluate the safety tolerability and immunogenicity of PRV-101 a coxsackie virus B vaccine in healthy volunteers
Detailed Description:
Thirty two healthy adult subjects will be enrolled into 2 dose cohorts low-dose and high-dose cohorts 16 subjects per cohort and will be randomized in a double-blind manner to PRV-101 or placebo in a 31 ratio Each subject will receive up to 3 administrations of the study drug PRV-101 or placebo at 4-week intervals and will be followed for 24 weeks after the final dose Each cohort will start with a sentinel dosing group 2 subjects Cohort 2 will commence after safety data from the first 2 doses from all Cohort 1 participants are reviewed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None