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NCT01585766 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT01585766: Completed Phase 1 study, sponsored by MedImmune.
NCT01585766 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01585766, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS).
Primary Outcome
An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE were the events between administration of study drug (Day 1) and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0
Interventions
- DRUG MEDI-551 30 MG-IV
- DRUG MEDI-551 60 MG-SC
- DRUG PLACEBO-IV-SC
- DRUG MEDI-551 100 MG-IV
- DRUG MEDI-551 300 MG-SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2012-04-24 |
| Est. Completion | 2016-06-20 |
| Phase | Phase 1 |
What the finished NCT01585766 record still lists
NCT01585766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which MEDI-551 30 MG-IV is the first listed.
NCT01585766 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01585766 about?
NCT01585766 is a clinical study titled "Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis". The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS).
What is the current status of trial NCT01585766?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2012-04-24. Estimated completion is 2016-06-20.
What interventions are being tested in trial NCT01585766?
The interventions under investigation include: MEDI-551 30 MG-IV (DRUG), MEDI-551 60 MG-SC (DRUG), PLACEBO-IV-SC (DRUG), MEDI-551 100 MG-IV (DRUG), MEDI-551 300 MG-SC (DRUG).
Who is sponsoring clinical trial NCT01585766?
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 NCT01585766's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 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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