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 |
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.
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.
(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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