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



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:6/10/2018
Start Date:December 7, 2015
End Date:December 9, 2016

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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

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.
We found this trial at
19
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