Study identifier:D5290C00001
ClinicalTrials.gov identifier:NCT02114268
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
Respiratory Syncytial Virus Infections
Phase 1
Yes
MEDI8897 Intravenous, Placebo, MEDI8897 Intramuscular
All
342
Interventional
18 Years - 49 Years
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verified 01 Oct 2016 by MedImmune, LLC
MedImmune, LLC
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: MEDI8897 300 milligram (mg) Intravenous (IV) Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. | Drug: MEDI8897 Intravenous Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. |
Experimental: MEDI8897 1000 mg IV Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. | Drug: MEDI8897 Intravenous Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. |
Experimental: MEDI8897 3000 mg IV Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. | Drug: MEDI8897 Intravenous Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. |
Experimental: MEDI8897 100 mg Intramuscular (IM) Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. | Drug: MEDI8897 Intramuscular Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. |
Experimental: MEDI8897 300 mg IM Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. | Drug: MEDI8897 Intramuscular Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. |
Placebo Comparator: Placebo Participants received placebo on Day 1. | Drug: Placebo Participants received placebo on Day 1. |