A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults

December 14, 2018 updated by: Genentech, Inc.

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, Administered as Monotherapy for the Treatment of Acute Uncomplicated Seasonal Influenza A Infection in Otherwise Healthy Adults

This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety and tolerability, efficacy, and pharmacokinetics of MHAA4549A.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1P 0A2
        • inVentiv Health Clinique
    • British Columbia
      • Vancouver, British Columbia, Canada, V6J 1S3
        • Manna Research Vancouver
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Moncton Hospital
    • Ontario
      • Toronto, Ontario, Canada, M9W 4L6
        • Manna Research
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 6S9
        • Q and T Research
  • Korea, Republic of
      • Anyang-si, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon-si,, Korea, Republic of, 420-767
        • Soon Chun Hyang University Hospital Bucheon
      • Incheon, Korea, Republic of
        • Gachon University Gil Hospital
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 07441
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Wonju, Korea, Republic of, 220-701
        • Wonju Christian Hospital
  • New Zealand
      • Auckland, New Zealand, 1010
        • Optimal Clinical Trials
      • Auckland, New Zealand, 0612
        • Henderson Medical Centre
      • Dunedin, New Zealand
        • RMC Medical Research Ltd
      • Tauranga, New Zealand, 3143
        • Tauranga Hospital
  • South Africa
      • Centurion, South Africa, 1692
        • Johese Clinical Research
      • Durban, South Africa, 4052
        • Durban International Clinical Research Site
      • Durban, South Africa, 4091
        • Vawda Z Private Practice
      • Durban, South Africa, 4092
        • Dr Peter John Sebastian; Dr PJ Sebastian
      • Groenkloof, South Africa, 0181
        • Into Research; Life Groenkloof Hospital Medical Centre
      • Johannesburg, South Africa, 2113
        • Newtown Clinical Research
      • Johannesburg, South Africa, 1500
        • Worthwhile Clinical Trials
      • Kempton Park, South Africa, 1619
        • Clinresco Centres (Pty) Ltd
      • Kempton Park, South Africa, 1619
        • Peermed Clinical Trial Centre
      • Klerksdorp, South Africa, 2574
        • Klerksdorp /Tshepong Hospital Complex
      • Krugersdorp, South Africa, 1739
        • DJW Navorsing
      • Lyttleton, South Africa, 0157
        • I Engelbrecht Research
      • Pretoria Gauteng Province, South Africa, 0087
        • Syzygy Clinical Research; Unit 3 to 7
      • Pretoria-West, South Africa, 0183
        • Jongaie Research
      • Queenswood, South Africa, 0121
        • Queenswood CTC
      • Soweto, South Africa, 2013
        • WITS Clinical Research
      • Welkom, South Africa, 9460
        • Welkom Clinical Trial Centre
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Mutua de Terrassa; Servicio de Oncologia
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07010
        • Hospital Universitario Son Espases
    • LA Rioja
      • Logroño, LA Rioja, Spain, 26006
        • Hospital San Pedro
    • Vizcaya
      • Galdacao, Vizcaya, Spain, 48960
        • Hospital de Galdakao
  • United Kingdom
      • Guildford, United Kingdom, GU2 7XP
        • Surrey Clinical Research Centre; University of Surrey
      • London, United Kingdom, EC1A 7BE
        • Barts and the London NHS Trust.
      • Middlesborough, United Kingdom, TS4 3BW
        • The James Cook University Hospital
  • United States
    • Alabama
      • Athens, Alabama, United States, 35611
        • North Alabama Research Center LLC
    • California
      • Costa Mesa, California, United States, 92626
        • WCCT Global, LLC
      • Fountain Valley, California, United States, 92708
        • Lalla-Reddy Medical Corporation
    • Colorado
      • Centennial, Colorado, United States, 80112
        • IMMUNOe Research Centers
    • Florida
      • Doral, Florida, United States, 33166
        • Integrity Clinical Research
      • Edgewater, Florida, United States, 32132
        • Riverside Clinical Research
      • Gainesville, Florida, United States, 32607
        • Sarkis Clinical Trials
      • Hialeah, Florida, United States, 33016
        • The Community Research of South Florida
      • Lauderhill, Florida, United States, 33319
        • Innovative Clinical Research, Inc.
      • Miami, Florida, United States, 33135
        • South Florida Research Center, Inc.
      • Miami, Florida, United States, 33144
        • Oceane7 Clinical Research
      • Saint Cloud, Florida, United States, 34769
        • Central Florida Internists
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
      • Trinity, Florida, United States, 34655
        • Advanced Research Institute, Inc.
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates
      • Wichita, Kansas, United States, 67205
        • Professional Research Network of Kansas
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Kentucky Lung Clinic
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • MedPharmics
      • Opelousas, Louisiana, United States, 70570
        • Acadiana Medicine Clinic
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center; Anne Arundel Health System
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48235
        • Sinai Grace Hospital
      • Detroit, Michigan, United States, 48201
        • Detroit Medical Center
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Barnes Jewish Hospital
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical Group
    • Nebraska
      • La Vista, Nebraska, United States, 68128
        • Barrett Clinic, P.C.
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Global Medical Institutes, LLC
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Center For Medical Research LLC
    • South Carolina
      • Boiling Springs, South Carolina, United States, 29316
        • Emergency MD
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • HCCA Clinical Research Solutions
      • Knoxville, Tennessee, United States, 37920
        • Clinical Research Solutions PC
      • Smyrna, Tennessee, United States, 37167
        • Clinical Research Solutions, LLC
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch at Galveston
      • Houston, Texas, United States, 77058
        • Centex Studies
      • Pharr, Texas, United States
        • Centex Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Otherwise healthy participants
  • Positive test for influenza A infection
  • No more than 72 hours elapsed between onset of influenza-like illness and start of study drug
  • Presence of at least one moderate or severe constitutional symptom such as headache, myalgia, fever, chills, fatigue, anorexia, or nausea PLUS one moderate or severe respiratory symptom such as cough, sore throat, or rhinorrhea
  • For women of childbearing potential: negative pregnancy test and agreement to use acceptable contraceptive methods for at least 120 days after study drug administration
  • For men: agreement to use acceptable contraceptive methods for at least 30 days after study drug administration

Exclusion Criteria:

  • Creatinine clearance less than or equal to (</=) 80 milliliters per minute (mL/min)
  • Any significant medical conditions or laboratory abnormalities
  • Clinical signs and symptoms consistent with otitis, bronchitis, sinusitis, or pneumonia or active bacterial infection
  • Use of antiviral therapy in the period from onset of influenza-like illness and prior to enrollment
  • Pregnancy at Screening or is currently pregnant or breastfeeding
  • Investigational therapy within 30 days or 5 half-lives prior to start of study drug, whichever is greater
  • Prior anti-influenza monoclonal antibody use
  • Receipt of a nasal influenza A vaccine within 14 days prior to Screening
  • Positive test for influenza B or influenza A+B within 2 weeks prior to study drug
  • History of significant tobacco use or drug/alcohol abuse
  • Chronic use of oral or inhaled corticosteroids within 30 days prior to Screening
  • Autoimmune disease, known immunodeficiency of any cause, or use of immunosuppressive medications
  • History of any chronic respiratory condition
  • Human immunodeficiency virus (HIV) with cluster of differentiation (CD) 4 count </= 200 cells per milliliter (cells/mL) in the past 12 months
  • Serious infection requiring oral or IV antibiotics within 14 days prior to Screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MHAA4549A 3600 milligrams (mg)
Participants will receive single-dose MHAA4549A, 3600 mg, by intravenous (IV) administration.
Drug: MHAA4549A
MHAA4549A will be administered as a single dose by IV administration.
Experimental: MHAA4549A 8400 mg
Participants will receive single-dose MHAA4549A, 8400 mg, by IV administration.
Drug: MHAA4549A
MHAA4549A will be administered as a single dose by IV administration.
Placebo Comparator: Placebo
Participants will receive single-dose placebo by IV administration.
Drug: Placebo
Placebo will be administered as a single dose by IV administration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events (AEs)
Time Frame: Baseline to Day 100
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
Baseline to Day 100

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Requiring Hospitalization for Influenza-Related Complications
Time Frame: Baseline to Day 100
Baseline to Day 100
Duration of Hospitalization for Influenza-Related Complications
Time Frame: Baseline to Day 100
Baseline to Day 100
Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections
Time Frame: Baseline to Day 100
Participants with antibiotic usage for secondary bacterial respiratory infections were identified by counting participants with AEs containing the terms, "pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory."
Baseline to Day 100
Percentage of Participants With Complications of Influenza
Time Frame: Baseline to Day 100
Participants with complications of influenza were identified by counting participants with AEs containing the terms, "pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory."
Baseline to Day 100
Percentage of Participants With Influenza A Relapse/Reinfection
Time Frame: Baseline to Day 100
Baseline to Day 100
Area Under the Concentration-Time Curve (AUC) of MHAA4549A
Time Frame: Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours)
The AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was measured in micrograms times hours per milliliter (mcg*h/mL).
Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours)
Maximum Serum Concentration (Cmax) of MHAA4549A
Time Frame: Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours)
Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours)
Time to Alleviation of Symptoms of Influenza A Infection
Time Frame: Baseline to Day 14
Time to alleviation of all 7 symptoms (i.e., nasal congestion, sore throat, cough, aches, fatigue, headaches, chills/sweats) was assessed using a rating scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe) for each symptom. The outcome was defined in two ways: time to a total symptom score of <=1 and time to a total symptom score of <=7. Resolution had to be maintained for 24 hours without use of symptom relief medications. For participants who were enrolled with mild symptoms, the symptom score had to be reduced by one point during the study duration.
Baseline to Day 14
Percentage of Participants With Influenza-Related Deaths
Time Frame: Baseline to Day 100
Baseline to Day 100

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GV29893
  • 2016-000425-40 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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