Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT01128556
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female subjects, 18 to 65 years of age
* Patients must demonstrate a positive reaction to a Histamine skin-prick test. Manifested by a histamine-induced wheal of \>3mm in diameter over the normal saline control after 15 minutes of elapsed time
Exclusion Criteria:
* Significant signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis)
* Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to visit 1
* Subjects who have dermatographism or other skin conditions which might interfere with the interpretation of the skin test results
* Subjects who are receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy
* Known hypersensitivity to the investigational product or to drugs with similar chemical properties
* Pregnancy and/or breast feeding
* Use of antihistamines, NSAIDS, steroids, or other drugs which may affect the skin-response
* Use of any medications or agents that are not specified above that may confound the interpretation of the results
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01128556
Study Brief:
Protocol Section:
NCT01128556