NCT03901846

Duration of ColdZyme® II

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Enzymatica AB · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The objective of this investigation is to verify that ColdZyme® is deposited onto the throat and estimate the half-life of the ColdZyme® solution in the oropharynx of human volunteers using a log-linear mixed-effects model (LMM).

Detailed description

The study is an Open Label, Non-Comparative study intended to verify the method used to measure the duration of ColdZyme®. Each participant will be his own control as samples are taken before application of ColdZyme and used as an internal control. Samples will be taken from the oropharyngeal membrane using a cotton swab before application, and 1, 3, 5, 10, 20, and 60 minutes after application. Glycerol will then be extracted from the swabs using water and the concentration of glycerol will be measured.

Conditions

• Common Cold

Interventions

Type	Name	Description
DEVICE	ColdZyme	ColdZyme is a Class I medical device (CE-marked) with the following composition: glycerol, water, Tris buffer, CaCl2, menthol and trypsin

Timeline

• Start date: 2019-05-07
• Primary completion: 2019-07-25
• Completion: 2019-07-25
• First posted: 2019-04-03
• Last updated: 2019-10-11

Locations

1 site across 1 country: Iceland