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

NCT01544348 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2014-12-30

Study results available
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Summary

Phase 1 study to evaluate the safety of MEDI4212.

Conditions

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.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01544348 on ClinicalTrials.gov