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Influenza APhase 2NCT02623322

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

A Phase 2 study testing MHAA4549A in people with Influenza A, run by Genentech, Inc. at 80 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Influenza A
What is being tested?
MHAA4549A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
80 sitesin 7 countries
Study dates
12 Oct 2016to 13 Nov 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

80 sites in 7 countries.

80 sites in 7 countries

United States38 sites

  • Anne Arundel Medical Center; Anne Arundel Health System

    Annapolis, Maryland, 21401

  • North Alabama Research Center LLC

    Athens, Alabama, 35611

  • Emergency MD

    Boiling Springs, South Carolina, 29316

  • Mercury Street Medical Group

    Butte, Montana, 59701

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112

  • WCCT Global, LLC

    Costa Mesa, California, 92626

  • Detroit Medical Center

    Detroit, Michigan, 48201

  • Sinai Grace Hospital

    Detroit, Michigan, 48235

  • Integrity Clinical Research

    Doral, Florida, 33166

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • Lalla-Reddy Medical Corporation

    Fountain Valley, California, 92708

  • HCCA Clinical Research Solutions

    Franklin, Tennessee, 37067

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555

  • Kentucky Lung Clinic

    Hazard, Kentucky, 41701

  • The Community Research Of South Florida

    Hialeah, Florida, 33016

  • Centex Studies

    Houston, Texas, 77058

  • Clinical Research Solutions PC

    Knoxville, Tennessee, 37920

  • Barrett Clinic, P.C.

    La Vista, Nebraska, 68128

  • Innovative Clinical Research, Inc.

    Lauderhill, Florida, 33319

  • MedPharmics

    Metairie, Louisiana, 70006

  • South Florida Research Center, Inc.

    Miami, Florida, 33135

  • Oceane7 Clinical Research

    Miami, Florida, 33144

  • Acadiana Medicine Clinic

    Opelousas, Louisiana, 70570

  • Centex Studies

    Pharr, Texas

  • Global Medical Institutes, LLC

    Princeton, New Jersey, 08540

  • Center For Medical Research LLC

    Providence, Rhode Island, 02908

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Central Florida Internists

    Saint Cloud, Florida, 34769

  • Clinical Research Solutions, LLC

    Smyrna, Tennessee, 37167

  • Barnes Jewish Hospital

    St Louis, Missouri, 63108

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Advanced Research Institute, Inc.

    Trinity, Florida, 34655

  • Professional Research Network of Kansas

    Wichita, Kansas, 67205

  • Heartland Research Associates

    Wichita, Kansas, 67207

  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

South Africa17 sites

  • Johese Clinical Research

    Centurion, 1692

  • Durban International Clinical Research Site

    Durban, 4052

  • Vawda Z Private Practice

    Durban, 4091

  • Dr Peter John Sebastian; Dr PJ Sebastian

    Durban, 4092

  • Into Research; Life Groenkloof Hospital Medical Centre

    Groenkloof, 0181

  • Worthwhile Clinical Trials

    Johannesburg, 1500

  • Newtown Clinical Research

    Johannesburg, 2113

  • Clinresco Centres (Pty) Ltd

    Kempton Park, 1619

  • Peermed Clinical Trial Centre

    Kempton Park, 1619

  • Klerksdorp /Tshepong Hospital Complex

    Klerksdorp, 2574

  • DJW Navorsing

    Krugersdorp, 1739

  • I Engelbrecht Research

    Lyttleton, 0157

  • Syzygy Clinical Research; Unit 3 to 7

    Pretoria Gauteng Province, 0087

  • Jongaie Research

    Pretoria West, 0183

  • Queenswood CTC

    Queenswood, 0121

  • Wits Clinical Research

    Soweto, 2013

  • Welkom Clinical Trial Centre

    Welkom, 9460

Other trials in South Africa

South Korea7 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, 14068

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, 420-767

  • Gachon University Gil Hospital

    Incheon

  • Korea University Anam Hospital

    Seoul, 02841

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441

  • Korea University Guro Hospital

    Seoul, 08308

  • Wonju Christian Hospital

    Wŏnju, 220-701

Other trials in South Korea

Spain6 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de Galdakao

    Galdacao, Vizcaya, 48960

  • Hospital San Pedro

    Logroño, La Rioja, 26006

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07010

  • Hospital Mutua de Terrassa; Servicio de Oncologia

    Terrassa, Barcelona, 08221

Other trials in Spain

Canada5 sites

  • Q and T Research

    Gatineau, Quebec, J8Y 6S9

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • inVentiv Health Clinique

    Québec, G1P 0A2

  • Manna Research

    Toronto, Ontario, M9W 4L6

  • Manna Research Vancouver

    Vancouver, British Columbia, V6J 1S3

Other trials in Canada

New Zealand4 sites

  • Henderson Medical Centre

    Auckland, 0612

  • Optimal Clinical Trials

    Auckland, 1010

  • RMC Medical Research Ltd

    Dunedin

  • Tauranga Hospital

    Tauranga, 3143

Other trials in New Zealand

United Kingdom3 sites

  • Surrey Clinical Research Centre; University of Surrey

    Guildford, GU2 7XP

  • Barts and the London NHS Trust.

    London, EC1A 7BE

  • The James Cook University Hospital

    Middlesbrough, TS4 3BW

Other trials in United Kingdom

About this study

Official title: 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.

Conditions
Influenza A
Being tested
MHAA4549A, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MHAA4549ADrug

    MHAA4549A will be administered as a single dose by IV administration.

  • PlaceboDrug

    Placebo will be administered as a single dose by IV administration.

Study groups in NCT02623322
Study groupRoleWhat they receive
MHAA4549A 3600 milligrams (mg)ExperimentalParticipants will receive single-dose MHAA4549A, 3600 mg, by intravenous (IV) administration.
Receives: Drug: MHAA4549A
MHAA4549A 8400 mgExperimentalParticipants will receive single-dose MHAA4549A, 8400 mg, by IV administration.
Receives: Drug: MHAA4549A
PlaceboPlacebo comparatorParticipants will receive single-dose placebo by IV administration.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events (AEs)

    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.

    Measured: Baseline to Day 100

Secondary outcomes (9)

  1. Percentage of Participants Requiring Hospitalization for Influenza-Related Complications

    Measured: Baseline to Day 100

  2. Duration of Hospitalization for Influenza-Related Complications

    Measured: Baseline to Day 100

  3. Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections

    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."

    Measured: Baseline to Day 100

  4. Percentage of Participants With Complications of Influenza

    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."

    Measured: Baseline to Day 100

  5. Percentage of Participants With Influenza A Relapse/Reinfection

    Measured: Baseline to Day 100

  6. Area Under the Concentration-Time Curve (AUC) of MHAA4549A

    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).

    Measured: 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)

  7. Maximum Serum Concentration (Cmax) of MHAA4549A

    Measured: 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)

  8. Time to Alleviation of Symptoms of Influenza A Infection

    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.

    Measured: Baseline to Day 14

  9. Percentage of Participants With Influenza-Related Deaths

    Measured: Baseline to Day 100

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2015 (estimated)
  2. Study start12 Oct 2016
  3. Primary completion13 Nov 2017
  4. Study completion13 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02623322
Sponsor's protocol ID
GV29893
Other IDs
2016-000425-40, 2016
Status last verified
Dec 2018
First submitted
3 Dec 2015
Last updated
8 Jan 2019
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MHAA4549A in people with Influenza A, run by Genentech, Inc. at 80 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, South Africa, South Korea, Spain, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AEs) (time frame: Baseline to Day 100). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02623322.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.

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