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:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT01018693
Eligibility Criteria:
Inclusion Criteria:
* History of atopy, defined as a history of seasonal allergic rhinitis for at least 2 years (in relation to the grass pollen allergy season), and evidence of atopy, defined as a positive skin prick test (wheal difference allergen - negative control at least 3 mm) to grass pollen allergen at screening.
* Male or female subjects aged between 18 and 60 years (inclusive)
* Female subjects must be of non-childbearing potential
* Subjects must weigh at least 50 kg with a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive)
* Informed consent
Exclusion Criteria:
* Treatment with intranasal corticosteroids within 28 days prior to the first dose.
* History of asthma with treatment with inhaled or systemic corticosteroids within 6 months of the first dose.
* History of COPD.
* Any exposure to human monoclonal or polyclonal antibodies.
* Any allergy immunotherapy within 3 years prior to screening.
* Any prior grass pollen allergy immunotherapy.
* FEV1 \< 70% of predicted at screening or baseline.
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01018693
Study Brief:
Protocol Section:
NCT01018693