Clinical trial NCT02603952: A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: Influenza
Influenza A
Flu
Flu A
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2015-11-13
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10
timeFrame: Day 1 (post-dose) through Day 10
measure: Number of Participants With Any Solicited Influenza Symptoms From Day 10 Through Day 13
timeFrame: Day 10 through Day 13
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 (post-dose) through Day 28
measure: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 (post-dose) through Day 101
measure: Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESIs)
timeFrame: Day 1 (post-dose) through Day 101
Secondary outcomes:
measure: Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)
timeFrame: Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13
measure: Quantitation of Influenza Viral Shedding as Measured by qRT-PCR
timeFrame: Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13
measure: Number of Days of Influenza Viral Shedding as Measured by qRT-PCR
timeFrame: From Baseline (Day 1) to Day 7; and Day 9 to Day 13
measure: Percentage of Participants With Amino Acid Changes in MEDI8852 Binding Site
timeFrame: From Baseline (Day 1) to Day 13
measure: Number of Participants With Viral Susceptibility to MEDI8852 as Determined by a Cell Based Microneutralization Assay
timeFrame: From Baseline (Day 1) to Day 13
measure: Percentage of Participants With Virus Containing Known Oseltamivir Resistance-Associated Mutations
timeFrame: From Baseline (Day 1) to Day 13
Other outcomes:
Locations:
city: Canoga Park
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Upland
country: United States
facility: Research Site
state: California
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: North Miami Beach
country: United States
facility: Research Site
state: Florida
city: Avon
country: United States
facility: Research Site
state: Indiana
city: Muncie
country: United States
facility: Research Site
state: Indiana
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Troy
country: United States
facility: Research Site
state: Michigan
city: Butte
country: United States
facility: Research Site
state: Montana
city: Hickory
country: United States
facility: Research Site
state: North Carolina
city: Shelby
country: United States
facility: Research Site
state: North Carolina
city: Smithfield
country: United States
facility: Research Site
state: Pennsylvania
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Clinton
country: United States
facility: Research Site
state: Utah
city: Brandfort
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Thabazimbi
country: South Africa
facility: Research Site
city: Welkom
country: South Africa
facility: Research Site
Study officials:
References:
citation: Ali SO, Takas T, Nyborg A, Shoemaker K, Kallewaard NL, Chiong R, Dubovsky F, Mallory RM. Evaluation of MEDI8852, an Anti-Influenza A Monoclonal Antibody, in Treating Acute Uncomplicated Influenza. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e00694-18. doi: 10.1128/AAC.00694-18. Print 2018 Nov.