Trials / Completed
CompletedNCT00198289
Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
A Phase IIa Dose Escalation Study to Assess Safety and Pharmacokinetics of Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (planned)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 7 Years
- Healthy volunteers
- Not accepted
Summary
Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed until Study Day 57. Aurexis is a humanized monoclonal antibody that is designed to combat Staphylococcus aureus. The purpose of this study is to assess the safety and pharmacokinetic profile (concentration of Aurexis in blood and sputum) of Aurexis. Additionally, certain tests and measurements will be conducted to preliminarily determine if Aurexis demonstrates any benefit to these patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aurexis® (tefibazumab) |
Timeline
- Start date
- 2005-04-01
- Completion
- 2006-06-01
- First posted
- 2005-09-20
- Last updated
- 2013-03-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00198289. Inclusion in this directory is not an endorsement.