A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
Condition: Allergic Asthma; Atopic Dermatitis; Allergic Rhinitis; Healthy Volunteers
MeSH terms: Rhinitis; Rhinitis, Allergic; Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo; Omalizumab; MEDI4212 5 mg Subcutaneous; MEDI4212 15 mg Subcutaneous; MEDI4212 60 mg Subcutaneous; MEDI4212 150 mg Subcutaneous; MEDI4212 300 mg Subcutaneous; MEDI4212 300 mg Intravenous
Intervention description: A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.; A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.; A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.; A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.; A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.; A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.; A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.; A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
Intervention MeSH terms: Omalizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Allergic; Atopic Dermatitis; MEDI4212

Summary:

      Phase 1 study to evaluate the safety of MEDI4212.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 through 60 years

          -  Written informed consent and any locally required authorization

          -  Body weight 45-150 kilogram (kg) for Cohorts 1-3, 4b, and 5-9. Body weight 45-90 kg
             for Cohort 4a

          -  Females must have been surgically sterilized or postmenopausal

          -  Non-sterilized males who are sexually active with a female partner of childbearing
             potential must use a highly effective method of contraception from Day 1 through Day
             85; Both partners to use contraception

          -  Sterilized males must be at least 1-year post vasectomy or use a highly effective
             contraceptive method

          -  Healthy Japanese population as determined by a responsible physician

          -  Current diagnosis of allergic rhinitis, allergic asthma, or atopic dermatitis (cohorts
             1-6) with a diagnostic immunoglobulin E (IgE) of 30 international units per milliliter
             (IU/mL) at Screening. Diagnostic IgE levels are further restricted for subjects
             enrolling into each cohort, with the following levels required at Screening: Cohorts 1
             and 2: 30-700 IU/mL; Cohort 3: 30-700 IU/mL (4 subjects), greater than (>) 700-1,200
             IU/mL (4 subjects), and >1,200 IU/mL (4 subjects); Cohort 4a: 30-500 IU/mL; Cohort 4b:
             >700 IU/mL; Cohorts 5 and 6: 30-700 IU/mL (4 subjects per cohort) and >700 IU/mL (6
             subjects per cohort) or Japanese Cohorts 7-9: greater than or equal to (>=) 30 IU/mL

          -  Nonsmoker for >=6 months

          -  Obsolete criteria as no longer require Positive in vitro IgE fluorescence enzyme
             immunoassay (FEIA) response

          -  A forced expiration volume in one second (FEV1) >= 80 percent (%) predicted in
             subjects with asthma. Non-asthmatic subjects with FEV1 >=80% predicted, or with FEV1
             less than (<) 80% predicted but who, in the opinion of the investigator, do not have
             lung disease

          -  Ability and willingness to complete the follow-up period through Day 85 as required by
             the protocol.

        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.