Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT03338556
Status:
COMPLETED
Last Update Posted:
2018-11-09
First Post:
2017-10-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Examine the Duration of Effect of PrEP-001 in Healthy Subjects Challenged With HRV-16
Sponsor:
Prep Biopharm Limited
Organization:
Study Overview
Official Title:
A Phase IIa, Randomised, Double-blind, Placebo-controlled Outpatients Study to Investigate the Duration of Effect and Safety of PrEP-001 Given Prophylactically in Healthy Subjects, Subsequently Challenged With Human Rhinovirus (HRV-16)
Status:
COMPLETED
Status Verified Date:
2018-11
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:
None
Brief Summary:
A study to examine the duration of effect of PrEP-001 in healthy subjects challenged with HRV-16
Detailed Description:
A phase IIa, randomised, double-blind, placebo-controlled study using outpatient setting to assess the prophylactic effect of repeated intranasal dosing of PrEP-001 in healthy subjects, subsequently challenged with HRV-16, on the changes in clinical symptoms when compared to placebo at two different dosing regimens
Study Oversight
Has Oversight DMC:
None
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?: