Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT02479750
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2015-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of ColdZyme® on Experimentally Induced Common Cold.
Sponsor:
Enzymatica AB
Organization:
Study Overview
Official Title:
Evaluation of ColdZyme® on Experimentally Induced Common Cold. -A Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers.
Status:
COMPLETED
Status Verified Date:
2019-02
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:
COLDPREVII
Brief Summary:
This study evaluates the performance of ColdZyme® mouth spray on prevention of common cold symptoms on experimentally induced rhinovirus upper respiratory tract infection in healthy volunteers. Half of participants will receive ColdZyme® mouth spray while the other half will receive placebo.
Detailed Description:
88 subjects will be inoculated with rhinovirus 16 via the nasal route. The subjects will be randomized 1:1 to ColdZyme® or placebo. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. The subjects will visit the investigational clinic on 6 occasions. During these visits the subjects will leave nasal (lavage) and pharyngeal (swab) samples for quantification of virus replication. All subjects will have a diary for scoring of cold symptoms.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: