A Phase 2a to Evaluate the Safety of MEDI8852 in Adults with Uncomplicated Influenza - MEDI8852
Study identifier:D6000C00002
ClinicalTrials.gov identifier:NCT02603952
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 2a, Randomized, Partial Double-blind, Single dose, Active-controlled, Dose Ranging Study to Evaluate the Safety of MEDI8852 in Adults with Acute, Uncomplicated Influenza
Medical condition
Influenza
Phase
Phase 1/2
Healthy volunteers
No
Study drug
Oseltamivir, MEDI8852, Placebo
Sex
All
Actual Enrollment
126
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 07 Dec 2015
Primary Completion Date: 09 Dec 2016
Study Completion Date: 09 Dec 2016
Study design
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 May 2018 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo + Oseltamivir 75 mg Participants will receive a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5. | Drug: Oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. Other Name: N/A Drug: Placebo Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1. Other Name: N/A |
| Experimental: MEDI8852 750 mg + Oseltamivir 75 mg Participants will receive a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. | Drug: Oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. Other Name: N/A Drug: MEDI8852 MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1. Other Name: N/A |
| Experimental: MEDI8852 3000 mg + Oseltamivir 75 mg Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. | Drug: Oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. Other Name: N/A Drug: MEDI8852 MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1. Other Name: N/A |
| Experimental: MEDI8852 3000 mg Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1. | Drug: MEDI8852 MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1. Other Name: N/A |
