Clinical trial
Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or…
NCT00192478 · MedImmune LLC, Industry · Completed
Key facts
| NCT number | NCT00192478 |
|---|---|
| Title | Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524 |
| Official title | A Phase 1/2, Open-Label, Repeat-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children at Risk for Serious RSV Disease |
| Lead sponsor | MedImmune LLC, Industry |
| Status | Completed |
| Phase | Phase 1/Phase 2 |
| Study type | Interventional |
| Conditions | Respiratory Syncytial Virus Infections |
| Intervention type | Biological |
| Interventions | Medi-524 |
| Enrollment | 217 |
| Start date | Feb 1, 2004 |
| Primary completion | May 1, 2006 |
| Completion | Aug 1, 2006 |
| First posted | Sep 19, 2005 |
| Last update posted | Jul 28, 2008 |
| Countries | Argentina, Chile |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: