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NCT01544361 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
A Phase 1 study of Healthy Subjects, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 125
- Enrollment target
- 1
- Study location
NCT01544361: Completed Phase 1 study of Healthy Subjects, sponsored by MedImmune.
NCT01544361 is a Phase 1 study of Healthy Subjects that has completed, run by MedImmune. The registered enrollment target is 125 participants, roughly in line with the 127-participant average among 69 other Healthy Subjects trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01544361, a Phase 1 study of Healthy Subjects, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 125 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects.
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
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL MEDI7814, 1 MG/KG
- BIOLOGICAL MEDI7814, 3 MG/KG
- BIOLOGICAL MEDI7814, 10 MG/KG
- BIOLOGICAL MEDI7814, 20 MG/KG
Study Locations (1)
Nebraska
- Research Site - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT01544361 record still lists
NCT01544361 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 127-participant average among 69 other Healthy Subjects trials with a reported enrollment target.
The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01544361 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT01544361 about?
NCT01544361 is a clinical study titled "A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers". This is a Phase 1 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects.
What is the current status of trial NCT01544361?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2012-01. Estimated completion is 2012-09.
What conditions does trial NCT01544361 study?
This clinical trial studies the following conditions: Healthy Subjects.
What interventions are being tested in trial NCT01544361?
The interventions under investigation include: Placebo (OTHER), MEDI7814, 1 MG/KG (BIOLOGICAL), MEDI7814, 3 MG/KG (BIOLOGICAL), MEDI7814, 10 MG/KG (BIOLOGICAL), MEDI7814, 20 MG/KG (BIOLOGICAL).
Who is sponsoring clinical trial NCT01544361?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01544361 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Subjects
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01544361's enrollment target sits among peer trials
125 11th of 69 higher than 59 of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects 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.
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