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OpenTrials
Completed

NCT Number: NCT03901846

Duration of ColdZyme® II

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cutis Clinical Research Center

Kopavogur, Iceland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ColdZyme

Device

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

Primary outcomes

  1. Duration of the ColdZyme barrier

    Time frame: 0-60 minutes

    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.

Sponsors and collaborators

Lead sponsor

Enzymatica AB

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2019
Registry last updated
Oct 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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