A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza
NCT ID: NCT02603952
Last Updated: 2018-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
126 participants
INTERVENTIONAL
2015-12-07
2016-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Oseltamivir
75 mg capsules orally BID from Day 1 to Day 5.
Placebo
Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1.
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.
Oseltamivir
75 mg capsules orally BID from Day 1 to Day 5.
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.
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.
Oseltamivir
75 mg capsules orally BID from Day 1 to Day 5.
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.
MEDI8852 3000 mg
Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1.
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.
Interventions
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Oseltamivir
75 mg capsules orally BID from Day 1 to Day 5.
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.
Placebo
Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1.
Eligibility Criteria
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Inclusion Criteria
* Symptomatic presumptive Influenza A infection with onset of symptoms less than or equal to (≤) 5 days prior to MEDI8852 administration and defined as the presence of:
* Fever of greater than or equal to (≥) 38.0 degrees Celsius (100.4 degrees Fahrenheit) at screening AND
* ≥ 1 moderate systemic symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) AND
* ≥ 1 moderate respiratory symptom (cough, sore throat, or nasal symptoms)
* Influenza A infection confirmed with positive rapid antigen test
* Able to complete the follow-up period through Day 101 as required by protocol (including telephone follow-up for Days 11 to 101)
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for at least 2 days prior to the first dose of investigational product and must agree to continue using such precautions through Day 101 of the study
Exclusion Criteria
* Receipt of influenza antiviral therapy within the preceding 14 days.
* Receipt of immunoglobulin or blood products within 6 months prior to screening.
* Known immunodeficiency due to illness, including human immunodeficiency virus (HIV), or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.
* Current clinical evidence of pneumonia.
* Active bacterial infection requiring treatment with oral or parenteral antibiotics.
* History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 3 years.
* Any planned surgical procedure before completion of Day 101.
18 Years
65 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Locations
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Research Site
Canoga Park, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Upland, California, United States
Research Site
Hialeah, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami Lakes, Florida, United States
Research Site
North Miami Beach, Florida, United States
Research Site
Avon, Indiana, United States
Research Site
Muncie, Indiana, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Troy, Michigan, United States
Research Site
Butte, Montana, United States
Research Site
Hickory, North Carolina, United States
Research Site
Shelby, North Carolina, United States
Research Site
Smithfield, Pennsylvania, United States
Research Site
San Antonio, Texas, United States
Research Site
Clinton, Utah, United States
Research Site
Durban, , South Africa
Research Site
Johannesburg, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Thabazimbi, , South Africa
Research Site
Welkom, , South Africa
Research Site
Winnie Mandela, , South Africa
Countries
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References
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Ali SO, Takas T, Nyborg A, Shoemaker K, Kallewaard NL, Chiong R, Dubovsky F, Mallory RM. Evaluation of MEDI8852, an Anti-Influenza A Monoclonal Antibody, in Treating Acute Uncomplicated Influenza. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e00694-18. doi: 10.1128/AAC.00694-18. Print 2018 Nov.
Other Identifiers
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D6000C00002
Identifier Type: -
Identifier Source: org_study_id
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