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NCT01769417 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893 in Healthy Adult Subjects
A Phase 1 study of Staphylococcus Aureus, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
- 1
- Study location
NCT01769417: Completed Phase 1 study of Staphylococcus Aureus, sponsored by MedImmune.
NCT01769417 is a Phase 1 study of Staphylococcus Aureus that has completed, run by MedImmune. The registered enrollment target is 85 participants, below the 3,893-participant average among 8 other Staphylococcus Aureus trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01769417, a Phase 1 study of Staphylococcus Aureus, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, first time in human study enrolling approximately 33 healthy adult subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MEDI4893 in healthy adult volunteers administered as a single IV dose compared with placebo, across 4 cohorts. The 4 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MEDI4893
Study Locations (1)
Florida
- Research Site - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT01769417 record still lists
NCT01769417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 3,893-participant average among 8 other Staphylococcus Aureus trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Staphylococcus Aureus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01769417 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01769417 about?
NCT01769417 is a clinical study titled "A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893 in Healthy Adult Subjects". This is a Phase 1, first time in human study enrolling approximately 33 healthy adult subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MEDI4893 in healthy adult volunteers administered as a single IV dose compared with placebo, acr...
What is the current status of trial NCT01769417?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2013-01. Estimated completion is 2014-05.
What conditions does trial NCT01769417 study?
This clinical trial studies the following conditions: Staphylococcus Aureus.
What interventions are being tested in trial NCT01769417?
The interventions under investigation include: Placebo (DRUG), MEDI4893 (DRUG).
Who is sponsoring clinical trial NCT01769417?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01769417 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01769417's enrollment target sits among peer trials
85 6th of 8 higher than 3 of 8 other Staphylococcus Aureus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Staphylococcus Aureus 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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