A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects with IgE >= 30 IU/mL

Exclusion Criteria

• - Any condition that, in the opinion of the investigator, would interfere with evaluation
• of the investigational product or interpretation of subject safety or study results
• - Concurrent enrollment in another clinical study
• - Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
• - Exposure to an anti-IgE monoclonal antibodies (MAb) within 12 months prior to Screening
• - Positive drug screen at Screening or Day -1. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines
• - History of regular alcohol abuse within 12 months prior to Screening
• - History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation
• - Subjects with abnormal liver function test values (aspartate transaminase [AST] and alanine transaminase [ALT]) at Screening as defined as follows: a) Liver function test values >= 1.5 times upper limit of normal (ULN)
• - Unwillingness or inability to follow the procedures outlined in the protocol
• - Positive test or history of hepatitis B or positive hepatitis C
• - Positive test or history of human immunodeficiency virus (HIV) or subject is known to be HIV seropositive
• - History of cancer, with the exception of basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success
• - Women who are pregnant, breastfeeding, or lactating
• - Plans to donate blood during the study period
• - Hyper-IgE syndrome or bronchopulmonary aspergillosis
• - Prior history of Immune Complex Disease or type 3 hypersensitivity reactions to MAb administration
• - Known history of prior infusion reaction to MAb administration
• - History of untreated parasitic/helminthic infection within 6 months prior to Screening
• - Uses any of the following medications: a) Oral corticosteroids b) Medium to high dose Immunocorticosteroids (ICS)/ long-acting beta agonists (LABA) c) Immunosuppressives d) Beta blockers
• - If receiving allergy immunotherapy, must be on stable dose for 3 months. Must not receive allergy immunotherapy within 7 days of investigational product administration.