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

Use our guide to learn which trials are right for you!

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
sites
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
179
mi
from 43215
Avon, IN
Click here to add this to my saved trials
?
mi
from 43215
Brandfort,
Click here to add this to my saved trials
1538
mi
from 43215
Butte, MT
Click here to add this to my saved trials
1987
mi
from 43215
Canoga Park, CA
Click here to add this to my saved trials
1518
mi
from 43215
Clinton, UT
Click here to add this to my saved trials
989
mi
from 43215
Hialeah, FL
Click here to add this to my saved trials
304
mi
from 43215
Hickory, NC
Click here to add this to my saved trials
1975
mi
from 43215
Long Beach, CA
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
?
mi
from 43215
Miami Lakes, FL
Click here to add this to my saved trials
125
mi
from 43215
Muncie, IN
Click here to add this to my saved trials
798
mi
from 43215
New Orleans, LA
Click here to add this to my saved trials
North Miami Beach, Florida 33162
983
mi
from 43215
North Miami Beach, FL
Click here to add this to my saved trials
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
332
mi
from 43215
Shelby, NC
Click here to add this to my saved trials
170
mi
from 43215
Smithfield, PA
Click here to add this to my saved trials
181
mi
from 43215
Troy, MI
Click here to add this to my saved trials
1939
mi
from 43215
Upland, CA
Click here to add this to my saved trials