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
Overview
- Phase
- Phase 1
- Intervention
- Oseltamivir
- Conditions
- Influenza
- Sponsor
- MedImmune LLC
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Number of Participants With Any Solicited Influenza Symptoms From Day 10 Through Day 13
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility 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.
Arms & Interventions
Placebo + Oseltamivir 75 mg
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.
Intervention: Oseltamivir
Placebo + Oseltamivir 75 mg
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.
Intervention: Placebo
MEDI8852 750 mg + Oseltamivir 75 mg
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.
Intervention: Oseltamivir
MEDI8852 750 mg + Oseltamivir 75 mg
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.
Intervention: MEDI8852
MEDI8852 3000 mg + Oseltamivir 75 mg
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.
Intervention: Oseltamivir
MEDI8852 3000 mg + Oseltamivir 75 mg
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.
Intervention: MEDI8852
MEDI8852 3000 mg
Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1.
Intervention: MEDI8852
Outcomes
Primary Outcomes
Number of Participants With Any Solicited Influenza Symptoms From Day 10 Through Day 13
Time Frame: Day 10 through Day 13
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Day 1 (post-dose) through Day 28
An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 28 that were absent before treatment or that worsened relative to pre-treatment state.
Number of Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10
Time Frame: Day 1 (post-dose) through Day 10
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: Day 1 (post-dose) through Day 101
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre-treatment state.
Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESIs)
Time Frame: Day 1 (post-dose) through Day 101
An AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. An AESI was one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre treatment state.
Secondary Outcomes
- Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)(Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13)
- Number of Days of Influenza Viral Shedding as Measured by qRT-PCR(From Baseline (Day 1) to Day 7; and Day 9 to Day 13)
- Percentage of Participants With Virus Containing Known Oseltamivir Resistance-Associated Mutations(From Baseline (Day 1) to Day 13)
- Quantitation of Influenza Viral Shedding as Measured by qRT-PCR(Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13)
- Percentage of Participants With Amino Acid Changes in MEDI8852 Binding Site(From Baseline (Day 1) to Day 13)
- Number of Participants With Viral Susceptibility to MEDI8852 as Determined by a Cell Based Microneutralization Assay(From Baseline (Day 1) to Day 13)