A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT02603952

Run by

MedImmune LLC

People needed

126

Starts

2015-12-07

Expected to finish

2016-12-09

Last updated by the study team

2018-06-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 through 65 years at the time of screening.
• 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

You may not qualify if…

• Hospitalized subjects.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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