Duration of ColdZyme® II

Common Cold Clinical Trial

Official title:

Duration of ColdZyme® II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901846
• Other study ID #: CI70
• Status: Completed
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: July 25, 2019

Study information

• Verified date: October 2019
• Source: Enzymatica AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 25, 2019
• Est. primary completion date: July 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy male or female subjects between 18-70 years. The investigator judges the definition of healthy by medical history.

• No reported symptoms of sore throat.

• Readiness to comply with trial procedures.

• Females of childbearing potential: should use reliable method of birth control.

• Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.

Exclusion Criteria:

• Known allergy or hypersensitivity to the components of the investigational product

• History and/or presence of clinically significant condition/disorder (self-reported), which per investigator's judgement could interfere with the results of the study or the safety of the subject.

• Any current cold symptom such as sore throat, sneezing, rhinorrhea, malaise, nasal obstruction or cough.

• Use of products, drugs, or food containing glycerol that may influence the study outcome, or concomitant medication with pharmaceuticals that might cause dry mouth (xerostomia), e.g. but not restricted to, morphine or morphine derivates, diuretics, antidepressants or other drugs with anticholinergic effect.

• Females: Pregnant or breast-feeding

• History of (in the past 12 months prior to study start) or current abuse of drugs, alcohol or medication

• Inability to comply with study requirements according to investigator's judgement

• Participation in another clinical study in the 30 days prior to enrolment and during the study

Related Conditions & MeSH terms

• Common Cold

Intervention

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

Locations

Country	Name	City	State
Iceland	Cutis Clinical Research Center	Kopavogur

Sponsors (1)

Lead Sponsor	Collaborator
Enzymatica AB

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the ColdZyme barrier	To measure the duration of the ColdZyme barrier following intra-oral deposition, by analyzing the oro-pharyngeal glycerol amount over time between 0 and 60 minutes after application.	0-60 minutes