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

MedImmune

Status and phase: Completed; Phase 2; Phase 1

Conditions: Influenza

Treatments: Drug: Placebo; Drug: MEDI8852; Drug: Oseltamivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02603952

D6000C00002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 4 patient groups, including a placebo group

Placebo + Oseltamivir 75 mg

Placebo Comparator group

Description:

Participants will receive a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5.

Treatment:

Drug: Oseltamivir

Drug: Placebo

MEDI8852 750 mg + Oseltamivir 75 mg

Experimental group

Description:

Participants will receive a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.

Treatment:

Drug: MEDI8852

Drug: Oseltamivir

MEDI8852 3000 mg + Oseltamivir 75 mg

Experimental group

Description:

Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5.

Treatment:

Drug: MEDI8852

Drug: Oseltamivir

MEDI8852 3000 mg

Experimental group

Description:

Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1.

Treatment:

Drug: MEDI8852