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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Oseltamivir
MEDI8852
Placebo
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza focused on measuring Influenza, Influenza A, Flu, Flu A

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Research Site
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  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo + Oseltamivir 75 mg

MEDI8852 750 mg + Oseltamivir 75 mg

MEDI8852 3000 mg + Oseltamivir 75 mg

MEDI8852 3000 mg

Arm 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.

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.

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.

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

Outcomes

Primary Outcome Measures

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).
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).
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.
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.
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.

Secondary Outcome Measures

Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)
Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure influenza viral shedding from the nasopharyngeal swabs. Percentage of participants who shed influenza virus are reported.
Quantitation of Influenza Viral Shedding as Measured by qRT-PCR
qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.
Number of Days of Influenza Viral Shedding as Measured by qRT-PCR
Number of days of viral shedding for participants who shed influenza virus is reported. qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.
Percentage of Participants With Amino Acid Changes in MEDI8852 Binding Site
Genotypic analysis was performed to identify all amino acid changes in MEDI8852 binding site between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with changes in the amino acid corresponding to MEDI8852 binding site is reported. Due to the fact that the percentage of participants with amino acid changes in MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.
Number of Participants With Viral Susceptibility to MEDI8852 as Determined by a Cell Based Microneutralization Assay
Viral susceptibility to MEDI8852 was measured by a Madin-Darby canine kidney (MDCK) cell-based microneutralization assay (Virospot) for viruses recovered from baseline samples and viruses recovered from samples following treatment that contain amino acid changes within the MEDI8852 binding site. Participants with detectable levels (50% tissue culture infectious dose [TCID50]) of virus were considered susceptible and were reported. Due to the fact that the number of participants with viral susceptibility to MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.
Percentage of Participants With Virus Containing Known Oseltamivir Resistance-Associated Mutations
Genotypic analysis was performed to identify all amino acid changes in neuraminidase (NA) gene between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with virus containing known oseltamivir resistance-associated mutations (change in the NA genes) is reported. Due to the fact that the percentage of participants with virus containing known oseltamivir resistance-associated mutation was zero across all participant samples analyzed, no additional per arm analyses were performed.

Full Information

First Posted
November 2, 2015
Last Updated
May 7, 2018
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02603952
Brief Title
A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza
Acronym
MEDI8852
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 7, 2015 (Actual)
Primary Completion Date
December 9, 2016 (Actual)
Study Completion Date
December 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Influenza A, Flu, Flu A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo + Oseltamivir 75 mg
Arm Type
Placebo Comparator
Arm 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.
Arm Title
MEDI8852 750 mg + Oseltamivir 75 mg
Arm Type
Experimental
Arm 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.
Arm Title
MEDI8852 3000 mg + Oseltamivir 75 mg
Arm Type
Experimental
Arm 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.
Arm Title
MEDI8852 3000 mg
Arm Type
Experimental
Arm Description
Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1.
Intervention Type
Drug
Intervention Name(s)
Oseltamivir
Intervention Description
75 mg capsules orally BID from Day 1 to Day 5.
Intervention Type
Drug
Intervention Name(s)
MEDI8852
Intervention Description
MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1.
Primary Outcome Measure Information:
Title
Number of Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10
Description
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Time Frame
Day 1 (post-dose) through Day 10
Title
Number of Participants With Any Solicited Influenza Symptoms From Day 10 Through Day 13
Description
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Time Frame
Day 10 through Day 13
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Day 1 (post-dose) through Day 28
Title
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Description
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.
Time Frame
Day 1 (post-dose) through Day 101
Title
Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESIs)
Description
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.
Time Frame
Day 1 (post-dose) through Day 101
Secondary Outcome Measure Information:
Title
Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)
Description
Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure influenza viral shedding from the nasopharyngeal swabs. Percentage of participants who shed influenza virus are reported.
Time Frame
Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13
Title
Quantitation of Influenza Viral Shedding as Measured by qRT-PCR
Description
qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.
Time Frame
Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13
Title
Number of Days of Influenza Viral Shedding as Measured by qRT-PCR
Description
Number of days of viral shedding for participants who shed influenza virus is reported. qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.
Time Frame
From Baseline (Day 1) to Day 7; and Day 9 to Day 13
Title
Percentage of Participants With Amino Acid Changes in MEDI8852 Binding Site
Description
Genotypic analysis was performed to identify all amino acid changes in MEDI8852 binding site between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with changes in the amino acid corresponding to MEDI8852 binding site is reported. Due to the fact that the percentage of participants with amino acid changes in MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.
Time Frame
From Baseline (Day 1) to Day 13
Title
Number of Participants With Viral Susceptibility to MEDI8852 as Determined by a Cell Based Microneutralization Assay
Description
Viral susceptibility to MEDI8852 was measured by a Madin-Darby canine kidney (MDCK) cell-based microneutralization assay (Virospot) for viruses recovered from baseline samples and viruses recovered from samples following treatment that contain amino acid changes within the MEDI8852 binding site. Participants with detectable levels (50% tissue culture infectious dose [TCID50]) of virus were considered susceptible and were reported. Due to the fact that the number of participants with viral susceptibility to MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.
Time Frame
From Baseline (Day 1) to Day 13
Title
Percentage of Participants With Virus Containing Known Oseltamivir Resistance-Associated Mutations
Description
Genotypic analysis was performed to identify all amino acid changes in neuraminidase (NA) gene between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with virus containing known oseltamivir resistance-associated mutations (change in the NA genes) is reported. Due to the fact that the percentage of participants with virus containing known oseltamivir resistance-associated mutation was zero across all participant samples analyzed, no additional per arm analyses were performed.
Time Frame
From Baseline (Day 1) to Day 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Research Site
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Research Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Research Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Research Site
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Research Site
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Research Site
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
Research Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Research Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Research Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Research Site
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Research Site
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Research Site
City
Brandfort
ZIP/Postal Code
9400
Country
South Africa
Facility Name
Research Site
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Research Site
City
Johannesburg
ZIP/Postal Code
2113
Country
South Africa
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
0087
Country
South Africa
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
0183
Country
South Africa
Facility Name
Research Site
City
Thabazimbi
ZIP/Postal Code
0380
Country
South Africa
Facility Name
Research Site
City
Welkom
ZIP/Postal Code
9460
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
30150460
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.
Results Reference
derived

Learn more about this trial

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

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