Duration of ColdZyme® II

NCT03901846 | Completed

• 1 other identifier: CI70
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ColdZyme

OTHER

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.

Device: ColdZyme

Interventions

ColdZyme DEVICE

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

ColdZyme

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Enzymatica AB: lead

Study Sites (1)

Cutis Clinical Research Center

Kopavogur, Iceland

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Bardur Sigurgeirsson, MD, PhD

  Cutis Clinical Research Center (CCRC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 3, 2019
• Study Start: May 7, 2019
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)