Study identifier:D6000C00002
ClinicalTrials.gov identifier:NCT02603952
EudraCT identifier:N/A
CTIS identifier:N/A
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
Influenza
Phase 1/2
No
Oseltamivir, MEDI8852, Placebo
All
126
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 May 2018 by MedImmune, LLC
MedImmune, LLC
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The purpose of this study is to evaluate safety and tolerability of a single dose of MEDI8852 when given with oseltamivir, the safety and tolerability of oseltamivir alone, and the safety and tolerability of a single dose of MEDI8852 alone in adult participants with acute, uncomplicated influenza caused by Type A strains.
The MEDI8852 phase 2a study will evaluate the safety and tolerability of a single intravenous (IV) dose of MEDI8852 administered in conjunction with oseltamivir, the safety and tolerability of oseltamivir alone and the safety and tolerability of a single IV dose of MEDI8852 alone in adult participants with confirmed acute, uncomplicated influenza caused by Type A strains. Enrollment is planned in the United States, South Africa, and Australia.
Location
Location
Hialeah, FL, United States, 33012
Location
Hialeah, FL, United States, 33013
Location
Clinton, UT, United States, 84015
Location
Shelby, NC, United States, 28150
Location
Miami, FL, United States, 33165
Location
Miami Lakes, FL, United States, 33014
Location
North Miami Beach, FL, United States, 33162
Location
Butte, MT, United States, 59701
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 |
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