A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza
MEDI8852
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
1 other identifier
interventional
126
2 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2015
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedStudy Start
First participant enrolled
December 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2016
CompletedResults Posted
Study results publicly available
June 8, 2018
CompletedJune 8, 2018
May 1, 2018
1 year
November 2, 2015
February 15, 2018
May 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Number of Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Day 1 (post-dose) through Day 10
Number of Participants With Any Solicited Influenza Symptoms From Day 10 Through Day 13
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Day 10 through Day 13
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Day 1 (post-dose) through Day 28
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
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.
Day 1 (post-dose) through Day 101
Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESIs)
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.
Day 1 (post-dose) through Day 101
Secondary Outcomes (6)
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
Quantitation of Influenza Viral Shedding as Measured by 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 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
- +1 more secondary outcomes
Study Arms (4)
Placebo + Oseltamivir 75 mg
PLACEBO COMPARATORParticipants 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.
MEDI8852 750 mg + Oseltamivir 75 mg
EXPERIMENTALParticipants 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.
MEDI8852 3000 mg + Oseltamivir 75 mg
EXPERIMENTALParticipants 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.
MEDI8852 3000 mg
EXPERIMENTALParticipants will receive a single IV infusion of MEDI8852 3000 mg on Day 1.
Interventions
75 mg capsules orally BID from Day 1 to Day 5.
MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1.
Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (31)
Research Site
Canoga Park, California, 91303, United States
Research Site
Long Beach, California, 90806, United States
Research Site
Los Angeles, California, 90017, United States
Research Site
Upland, California, 91786, United States
Research Site
Hialeah, Florida, 33012, United States
Research Site
Hialeah, Florida, 33013, United States
Research Site
Hialeah, Florida, 33016, United States
Research Site
Miami, Florida, 33165, United States
Research Site
Miami, Florida, 33173, United States
Research Site
Miami, Florida, 33185, United States
Research Site
Miami Lakes, Florida, 33014, United States
Research Site
North Miami Beach, Florida, 33162, United States
Research Site
Avon, Indiana, 46123, United States
Research Site
Muncie, Indiana, 47304, United States
Research Site
New Orleans, Louisiana, 70124, United States
Research Site
Troy, Michigan, 48085, United States
Research Site
Butte, Montana, 59701, United States
Research Site
Hickory, North Carolina, 28602, United States
Research Site
Shelby, North Carolina, 28150, United States
Research Site
Smithfield, Pennsylvania, 15478, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Clinton, Utah, 84015, United States
Research Site
Durban, 4001, South Africa
Research Site
Johannesburg, 2113, South Africa
Research Site
Pretoria, 0087, South Africa
Research Site
Pretoria, 0157, South Africa
Research Site
Pretoria, 0181, South Africa
Research Site
Pretoria, 0183, South Africa
Research Site
Thabazimbi, 0380, South Africa
Research Site
Welkom, 9460, South Africa
Research Site
Winnie Mandela, 9400, South Africa
Related Publications (1)
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.
PMID: 30150460DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Raburn Mallory
- Organization
- MedImmune, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2015
First Posted
November 13, 2015
Study Start
December 7, 2015
Primary Completion
December 9, 2016
Study Completion
December 9, 2016
Last Updated
June 8, 2018
Results First Posted
June 8, 2018
Record last verified: 2018-05