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

Part of paid clinical trials in Cypress, California.

Sponsor
MedImmune LLC
Study ID
NCT01544348
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — OTHER
    A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
  • Omalizumab — BIOLOGICAL
    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.
  • MEDI4212 5 mg Subcutaneous — BIOLOGICAL
    A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
  • MEDI4212 15 mg Subcutaneous — BIOLOGICAL
    A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
  • MEDI4212 60 mg Subcutaneous — BIOLOGICAL
    A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
  • MEDI4212 150 mg Subcutaneous — BIOLOGICAL
    A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
  • MEDI4212 300 mg Subcutaneous — BIOLOGICAL
    A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
  • MEDI4212 300 mg Intravenous — BIOLOGICAL
    A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.

Study Details

Phase 1 study to evaluate the safety of MEDI4212.

Key Dates

Start date
Jan 31, 2012
Status verified
Dec 2014
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013

Study Design

Enrollment
295 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
  • Active Comparator: 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.
  • Experimental: MEDI4212 5 mg Subcutaneous
    A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
  • Experimental: MEDI4212 15 mg Subcutaneous
    A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
  • Experimental: MEDI4212 60 mg Subcutaneous
    A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
  • Experimental: MEDI4212 150 mg Subcutaneous
    A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
  • Experimental: MEDI4212 300 mg Subcutaneous
    A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
  • Experimental: MEDI4212 300 mg Intravenous
    A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 to 85 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Research SiteCypressCalifornia--
Research SiteGlendaleCalifornia--
Research SiteDenverColorado--
Research SiteMiamiFlorida--
Research SiteBaltimoreMaryland--
Research SitePittsburghPennsylvania--
Research SiteMadisonWisconsin--

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