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Duration of ColdZyme® II

Primary Purpose

Common Cold

Status

Completed

Phase

Not Applicable

Locations

Iceland

Study Type

Interventional

Intervention

ColdZyme

About this trial

This is an interventional other trial for Common Cold

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Cutis Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ColdZyme

Arm Description

The study is 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03901846

First Posted

April 2, 2019

Last Updated

October 10, 2019

Sponsor

Enzymatica AB

1. Study Identification

Unique Protocol Identification Number

NCT03901846

Brief Title

Duration of ColdZyme® II

Official Title

Duration of ColdZyme® II

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

May 7, 2019 (Actual)

Primary Completion Date

July 25, 2019 (Actual)

Study Completion Date

July 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Enzymatica AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Common Cold

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ColdZyme

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

ColdZyme

Intervention Description

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

Primary Outcome Measure Information:

Title

Duration of the ColdZyme barrier

Description

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.

Time Frame

0-60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bardur Sigurgeirsson, MD, PhD

Organizational Affiliation

Cutis Clinical Research Center (CCRC)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cutis Clinical Research Center

City

Kopavogur

Country

Iceland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Duration of ColdZyme® II

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