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

PHASE1CompletedINTERVENTIONAL
Enrollment

295

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Allergic AsthmaAtopic DermatitisAllergic RhinitisHealthy Volunteers
Interventions
OTHER

Placebo

A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.

BIOLOGICAL

Omalizumab

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.

BIOLOGICAL

MEDI4212 5 mg Subcutaneous

A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.

BIOLOGICAL

MEDI4212 15 mg Subcutaneous

A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.

BIOLOGICAL

MEDI4212 60 mg Subcutaneous

A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.

BIOLOGICAL

MEDI4212 150 mg Subcutaneous

A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.

BIOLOGICAL

MEDI4212 300 mg Subcutaneous

A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.

BIOLOGICAL

MEDI4212 300 mg Intravenous

A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.

Trial Locations (7)

Unknown

Research Site, Cypress

Research Site, Glendale

Research Site, Denver

Research Site, Miami

Research Site, Baltimore

Research Site, Pittsburgh

Research Site, Madison

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY