CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 295 enrolled
Drug / intervention
Omalizumab +7 morebiological
Likely dose
MEDI4212 5 mg Subcutaneousfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01544348
NCT01544348Phase 1Completed

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

MedImmune LLC·interventional·Posted Mar 5, 2012·Updated Dec 30, 2014

In Brief

A Phase 1 clinical trial evaluating Placebo, Omalizumab, and 6 other interventions for Allergic Asthma and 3 related conditions. Completed, enrolled 295 participants across 7 sites.

Detailed Summary

Phase 1 study to evaluate the safety of MEDI4212.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2012
Enrollment StartJan 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.3 years ago

Interventions

Placeboother

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

Omalizumabbiological

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 Subcutaneousbiological

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

MEDI4212 15 mg Subcutaneousbiological

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

MEDI4212 60 mg Subcutaneousbiological

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

MEDI4212 150 mg Subcutaneousbiological

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

MEDI4212 300 mg Subcutaneousbiological

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

MEDI4212 300 mg Intravenousbiological

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