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

• Status: Completed
• Trial end date: 2016-12-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC
• Treatments: MEDI8852; Oseltamivir

Criteria

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.