Phase 1 study to evaluate the safety of MEDI4212.
A Phase 1, randomized, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of ascending single subcutaneous and intravenous doses of MEDI4212 in subjects with immunoglobulin E (IgE) greater than or equal to (\>=) 30 international units per milliliters (IU/mL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
295
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.
Research Site
Cypress, California, United States
Research Site
Glendale, California, United States
Research Site
Denver, Colorado, United States
Research Site
Miami, Florida, United States
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: Day 1 to 85
Observed Serum Concentration
Serum concentration of omalizumab and MEDI4212 were measured for participants who received omalizumab and MEDI4212, respectively.
Time frame: Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85
Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit
Anti-drug antibodies for MEDI4212 were analyzed for participants who received placebo or MEDI4212 as per planned analysis.
Time frame: Days 1 (pre-dose), 15, 43, and 85
Free Immunoglobulin E (IgE) Serum Concentration
Time frame: Day -28 (Screening), -1, 1 (pre-dose), 2, 3, 5, 8, 15, 22, 29, 43, 57, and 85 for all groups; 2 hours post-dose on Day 1 for MEDI4212 300 mg Intravenous group only
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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.
Research Site
Baltimore, Maryland, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Madison, Wisconsin, United States