Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||1 Month - 5 Years|
- - Male or female subjects aged 1 month to 5 years at Screening Visit - Subjects with clinical symptoms suggestive of non-IgE mediated Cow's Milk Allergy - Subjects with any type of diet containing regular cow's milk protein (e.g. cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk) within 1 month prior to Screening Visit - Subjects/parents/guardians who agree to follow a strict cow's milk-free diet and other mammalian milks (such as sheep and goat's milk) as per study requirements.
- - Subjects with an established diagnosis of non-IgE mediated CMA - Breast-fed subject at Screening Visit - Subjects with a convincing history of IgE-mediated CMA - Subjects on a cow's milk protein-free diet including an AA-based formula or an extensively hydrolyzed formula within 1 month of Screening Visit.
- - Generalized dermatologic disease (e.g. severe atopic dermatitis, ) extending widely on the skin.
Inclusion Criteria:- Male or female subjects aged 1 month to 5 years at Screening visit - Subjects having no medical history of any type of allergy - Subjects who tolerate at least 200 mL of cow's milk or equivalent dairy foods daily within 1 month prior to Screening visit
Exclusion Criteria:- Subjects with history of persistent gastro-intestinal symptoms - Breast-fed subjects
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Canada, Lithuania, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Cow's Milk Allergy|
Experimental: Disease group
One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA
Experimental: Control group
One active patch and one control patch applied to subjects without any history of allergic disease
Combination Product: - DBV1605
Ready-to-use atopy patch test for diagnostic use containing 2 distinct patches: One active patch containing a dry deposit of 180 μg of cow's milk proteins One control patch with the same design as the active patch but devoid of any formulation.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.