A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
Study identifier:D5290C00001
ClinicalTrials.gov identifier:NCT02114268
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
Medical condition
Respiratory Syncytial Virus Infections
Phase
Phase 1
Healthy volunteers
Yes
Study drug
MEDI8897 Intravenous, Placebo, MEDI8897 Intramuscular
Sex
All
Actual Enrollment
342
Study type
Interventional
Age
18 Years - 49 Years
Date
Study Start Date: 01 Apr 2014
Primary Completion Date: 01 Jun 2015
Study Completion Date: 01 Jun 2015
Study design
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verification:
Verified 01 Oct 2016 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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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. |
Contacts
Investigators
Principal Investigator
M. Pamela Griffin
MedImmune, LLC
