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A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy adult participants.
Details
| Lead sponsor | MedImmune LLC |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 342 |
| Start date | 2014-04 |
| Completion | 2015-06 |
Conditions
- Respiratory Syncytial Virus Infections
Interventions
- MEDI8897 Intravenous
- Placebo
- MEDI8897 Intravenous
- MEDI8897 Intravenous
- MEDI8897 Intramuscular
- MEDI8897 Intramuscular
Primary outcomes
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) — From start of study drug administration up to Day 391 (Day 361 +/- 30 days)
An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.
Countries
United States