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NCT01544348 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 295
- Enrollment target
NCT01544348: Completed Phase 1 study, sponsored by MedImmune.
NCT01544348 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 295 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (392% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01544348, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 295 participants
- Enrollment target
Study Summary
Phase 1 study to evaluate the safety of MEDI4212.
Primary Outcome
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 ad
Interventions
- OTHER Placebo
- BIOLOGICAL Omalizumab
- BIOLOGICAL MEDI4212 5 mg Subcutaneous
- BIOLOGICAL MEDI4212 15 mg Subcutaneous
- BIOLOGICAL MEDI4212 60 mg Subcutaneous
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 295 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
What the finished NCT01544348 record still lists
NCT01544348 is an interventional study that assigns participants to a tested intervention. The registered 295 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (392% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01544348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01544348 about?
NCT01544348 is a clinical study titled "A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL". Phase 1 study to evaluate the safety of MEDI4212.
What is the current status of trial NCT01544348?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 295 participants. The study started on 2012-01. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01544348?
The interventions under investigation include: Placebo (OTHER), Omalizumab (BIOLOGICAL), MEDI4212 5 mg Subcutaneous (BIOLOGICAL), MEDI4212 15 mg Subcutaneous (BIOLOGICAL), MEDI4212 60 mg Subcutaneous (BIOLOGICAL).
Who is sponsoring clinical trial NCT01544348?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01544348's enrollment target sits among peer trials
295 135th of 2000 higher than 1,866 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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