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CompletedNCT02623322Updated Jan 8, 2019Results posted

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

A Phase 2 interventional study of MHAA4549A and Placebo in Influenza A, sponsored by Genentech, Inc.. Completed at 80 sites in 7 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-08.

Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Influenza A

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 124 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
124 participants (actual)

Study arms

  • Experimental
    MHAA4549A 3600 milligrams (mg)

    Participants will receive single-dose MHAA4549A, 3600 mg, by intravenous (IV) administration.

    Drug: MHAA4549A

  • Experimental
    MHAA4549A 8400 mg

    Participants will receive single-dose MHAA4549A, 8400 mg, by IV administration.

    Drug: MHAA4549A

  • Placebo comparator
    Placebo

    Participants will receive single-dose placebo by IV administration.

    Drug: Placebo

Interventions

  • DrugMHAA4549A

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: Baseline to Day 100

Secondary outcomes

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

    Time frame: Baseline to Day 100

  2. Duration of Hospitalization for Influenza-Related Complications

    Time frame: 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."

    Time frame: 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."

    Time frame: Baseline to Day 100

  5. Percentage of Participants With Influenza A Relapse/Reinfection

    Time frame: 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).

    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)

  7. 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)

  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.

    Time frame: Baseline to Day 14

  9. Percentage of Participants With Influenza-Related Deaths

    Time frame: Baseline to Day 100

07

Results

Posted Jan 8, 2019

Participant flow

The study was conducted at 34 investigational sites in 6 countries including the United States (15 centers), South Africa (12 centers), Canada, Spain, New Zealand (2 centers in each country), and Great Britain (1 center).

Participant flow — Overall Study
MilestonePlaceboMHAA4549A 3600 mgMHAA4549A 8400 mg
Started434140
Completed414040
Not completed210
Withdrew: Lost to follow-up210

Outcome measures

PrimaryPercentage 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.

Time frame:
Baseline to Day 100
Reported as:
Number · percentage of participants
Percentage of Participants With Adverse Events (AEs)
percentage of participantsPlaceboMHAA4549A 3600 mgMHAA4549A 8400 mg
Percentage of Participants With Adverse Events (AEs)30.239.030.0
SecondaryPercentage of Participants Requiring Hospitalization for Influenza-Related Complications
Time frame:
Baseline to Day 100
Reported as:
Number · percentage of participants
Percentage of Participants Requiring Hospitalization for Influenza-Related Complications
percentage of participantsPlaceboMHAA4549A 3600 mgMHAA4549A 8400 mg
Percentage of Participants Requiring Hospitalization for Influenza-Related Complications000
SecondaryDuration of Hospitalization for Influenza-Related Complications
Time frame:
Baseline to Day 100
Reported as:
Number · days
Duration of Hospitalization for Influenza-Related Complications
daysPlaceboMHAA4549A 3600 mgMHAA4549A 8400 mg
Duration of Hospitalization for Influenza-Related Complications000
SecondaryPercentage 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."

Time frame:
Baseline to Day 100
Reported as:
Number · percentage of participants
Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections
percentage of participantsPlaceboMHAA4549A 3600 mgMHAA4549A 8400 mg
Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections3.0 (0.32 to 11.28)0 (0.00 to 6.37)0 (0.00 to 7.16)
Statistical analysis
  • Placebo vs MHAA4549A 3600 mg · Cochran-Mantel-Haenszel · p = 0.3031 · Difference in event rates (wald): -3.03 · 80% CI -12.25 to 6.19
  • Placebo vs MHAA4549A 8400 mg · Cochran-Mantel-Haenszel · p = 0.3324 · Difference in event rates (wald): -3.03 · 80% CI -12.82 to 6.76
SecondaryPercentage 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."

Time frame:
Baseline to Day 100
Reported as:
Number · percentage of participants
Percentage of Participants With Complications of Influenza
percentage of participantsPlaceboMHAA4549A 3600 mgMHAA4549A 8400 mg
Percentage of Participants With Complications of Influenza3.0 (0.32 to 11.28)0 (0.00 to 6.37)0 (0.00 to 7.16)
Statistical analysis
  • Placebo vs MHAA4549A 3600 mg · Cochran-Mantel-Haenszel · p = 0.3031 · Difference in event rates (wald): -3.03 · 80% CI -12.25 to 6.19
  • Placebo vs MHAA4549A 8400 mg · Cochran-Mantel-Haenszel · p = 0.3324 · Difference in event rates (wald): -3.03 · 80% CI -12.82 to 6.76
SecondaryPercentage of Participants With Influenza A Relapse/Reinfection
Time frame:
Baseline to Day 100
Reported as:
Number · percentage of participants
Percentage of Participants With Influenza A Relapse/Reinfection
percentage of participantsPlaceboMHAA4549A 3600 mgMHAA4549A 8400 mg
Percentage of Participants With Influenza A Relapse/Reinfection000
SecondaryArea 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).

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)

No measurements were reported for this outcome.

SecondaryMaximum 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)
Reported as:
Mean · mcg/mL
Maximum Serum Concentration (Cmax) of MHAA4549A
mcg/mLMHAA4549A 3600 mgMHAA4549A 8400 mg
Maximum Serum Concentration (Cmax) of MHAA4549A1050 ± 2992190 ± 581
SecondaryTime 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.

Time frame:
Baseline to Day 14
Reported as:
Median · hours
Time to Alleviation of Symptoms of Influenza A Infection
hoursPlaceboMHAA4549A 3600 mgMHAA4549A 8400 mg
Total Symptom Score of <=1117.30 (108.62 to 157.15)153.80 (125.52 to 175.23)145.82 (132.98 to 156.68)
Total Symptom Score of <=744.50 (27.23 to 58.65)74.18 (64.32 to 87.98)65.59 (44.12 to 87.23)
Statistical analysis
  • Placebo vs MHAA4549A 3600 mg · Wilcoxon · p = 0.7858 · Hazard ratio (hr): 0.92 · 80% CI 0.62 to 1.37
  • Placebo vs MHAA4549A 8400 mg · Wilcoxon · p = 0.5170 · Hazard ratio (hr): 0.90 · 80% CI 0.59 to 1.36
  • Placebo vs MHAA4549A 3600 mg · Wilcoxon · p = 0.0312 · Hazard ratio (hr): 0.63 · 80% CI 0.45 to 0.89
  • Placebo vs MHAA4549A 8400 mg · Wilcoxon · p = 0.2044 · Hazard ratio (hr): 0.74 · 80% CI 0.53 to 1.04
SecondaryPercentage of Participants With Influenza-Related Deaths
Time frame:
Baseline to Day 100
Reported as:
Number · percentage of participants
Percentage of Participants With Influenza-Related Deaths
percentage of participantsPlaceboMHAA4549A 3600 mgMHAA4549A 8400 mg
Percentage of Participants With Influenza-Related Deaths000

Adverse events

Collected over Baseline to Day 100. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/43 (0%)0/43 (0%)4/43 (9.3%)
MHAA4549A 3600 mg0/41 (0%)0/41 (0%)7/41 (17.1%)
MHAA4549A 8400 mg0/40 (0%)1/40 (2.5%)6/40 (15%)
Most frequent serious events
Most frequent serious events
EventPlaceboMHAA4549A 3600 mgMHAA4549A 8400 mg
Atrial fibrillationCardiac disorders0/430/411/40
Most frequent other events
Most frequent other events
EventPlaceboMHAA4549A 3600 mgMHAA4549A 8400 mg
NauseaGastrointestinal disorders2/433/413/40
BronchitisInfections and infestations1/433/411/40
Oropharyngeal painRespiratory, thoracic and mediastinal disorders1/431/412/40

Baseline characteristics

The safety population included all participants randomized to treatment.

Age, Continuous
Age, Continuous(years)PlaceboMHAA4549A 3600 mgMHAA4549A 8400 mgTotal
Mean39.3 ± 10.836.5 ± 12.535.0 ± 13.637.0 ± 12.4
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboMHAA4549A 3600 mgMHAA4549A 8400 mgTotal
Female27222271
Male16191853
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboMHAA4549A 3600 mgMHAA4549A 8400 mgTotal
Hispanic or Latino2327
Not Hispanic or Latino403838116
Not Stated1001
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboMHAA4549A 3600 mgMHAA4549A 8400 mgTotal
Asian2417
Black or African American1371535
Native Hawaiian or Other Pacific Islander1203
White27262376
Multiple0011
Unknown0202
08

Study locations

80 sites
  • North Alabama Research Center LLC
    Athens, Alabama 35611, United States
  • WCCT Global, LLC
    Costa Mesa, California 92626, United States
  • Lalla-Reddy Medical Corporation
    Fountain Valley, California 92708, United States
  • IMMUNOe Research Centers
    Centennial, Colorado 80112, United States
  • Integrity Clinical Research
    Doral, Florida 33166, United States
  • Riverside Clinical Research
    Edgewater, Florida 32132, United States
  • Sarkis Clinical Trials
    Gainesville, Florida 32607, United States
  • The Community Research Of South Florida
    Hialeah, Florida 33016, United States
  • Innovative Clinical Research, Inc.
    Lauderhill, Florida 33319, United States
  • South Florida Research Center, Inc.
    Miami, Florida 33135, United States
  • Oceane7 Clinical Research
    Miami, Florida 33144, United States
  • Central Florida Internists
    Saint Cloud, Florida 34769, United States
  • Tampa General Hospital
    Tampa, Florida 33606, United States
  • Advanced Research Institute, Inc.
    Trinity, Florida 34655, United States
  • Cotton O'Neil Clinical Research Center
    Topeka, Kansas 66606, United States
  • Professional Research Network of Kansas
    Wichita, Kansas 67205, United States
  • Heartland Research Associates
    Wichita, Kansas 67207, United States
  • Kentucky Lung Clinic
    Hazard, Kentucky 41701, United States
  • MedPharmics
    Metairie, Louisiana 70006, United States
  • Acadiana Medicine Clinic
    Opelousas, Louisiana 70570, United States
  • Anne Arundel Medical Center; Anne Arundel Health System
    Annapolis, Maryland 21401, United States
  • UMASS Memorial Medical Center
    Worcester, Massachusetts 01655, United States
  • Detroit Medical Center
    Detroit, Michigan 48201, United States
  • Sinai Grace Hospital
    Detroit, Michigan 48235, United States
  • William Beaumont Hospital
    Royal Oak, Michigan 48073, United States
  • Barnes Jewish Hospital
    Saint Louis, Missouri 63108, United States
  • Mercury Street Medical Group
    Butte, Montana 59701, United States
  • Barrett Clinic, P.C.
    La Vista, Nebraska 68128, United States
  • Global Medical Institutes, LLC
    Princeton, New Jersey 08540, United States
  • Wake Research Associates
    Raleigh, North Carolina 27612, United States
  • Center For Medical Research LLC
    Providence, Rhode Island 02908, United States
  • Emergency MD
    Boiling Springs, South Carolina 29316, United States
  • HCCA Clinical Research Solutions
    Franklin, Tennessee 37067, United States
  • Clinical Research Solutions PC
    Knoxville, Tennessee 37920, United States
  • Clinical Research Solutions, LLC
    Smyrna, Tennessee 37167, United States
  • University of Texas Medical Branch at Galveston
    Galveston, Texas 77555, United States
  • Centex Studies
    Houston, Texas 77058, United States
  • Centex Studies
    Pharr, Texas, United States
  • Manna Research Vancouver
    Vancouver, British Columbia V6J 1S3, Canada
  • Moncton Hospital
    Moncton, New Brunswick E1C 6Z8, Canada
  • Manna Research
    Toronto, Ontario M9W 4L6, Canada
  • Q and T Research
    Gatineau, Quebec J8Y 6S9, Canada
  • inVentiv Health Clinique
    Quebec, G1P 0A2, Canada
  • Hallym University Sacred Heart Hospital
    Anyang-si, 14068, Korea, Republic of
  • Soon Chun Hyang University Hospital Bucheon
    Bucheon-si,, 420-767, Korea, Republic of
  • Gachon University Gil Hospital
    Incheon, Korea, Republic of
  • Korea University Anam Hospital
    Seoul, 02841, Korea, Republic of
  • Hallym University Kangnam Sacred Heart Hospital
    Seoul, 07441, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, 08308, Korea, Republic of
  • Wonju Christian Hospital
    Wonju, 220-701, Korea, Republic of
  • Henderson Medical Centre
    Auckland, 0612, New Zealand
  • Optimal Clinical Trials
    Auckland, 1010, New Zealand
  • RMC Medical Research Ltd
    Dunedin, New Zealand
  • Tauranga Hospital
    Tauranga, 3143, New Zealand
  • Johese Clinical Research
    Centurion, 1692, South Africa
  • Durban International Clinical Research Site
    Durban, 4052, South Africa
  • Vawda Z Private Practice
    Durban, 4091, South Africa
  • Dr Peter John Sebastian; Dr PJ Sebastian
    Durban, 4092, South Africa
  • Into Research; Life Groenkloof Hospital Medical Centre
    Groenkloof, 0181, South Africa
  • Worthwhile Clinical Trials
    Johannesburg, 1500, South Africa
  • Newtown Clinical Research
    Johannesburg, 2113, South Africa
  • Clinresco Centres (Pty) Ltd
    Kempton Park, 1619, South Africa
  • Peermed Clinical Trial Centre
    Kempton Park, 1619, South Africa
  • Klerksdorp /Tshepong Hospital Complex
    Klerksdorp, 2574, South Africa
  • DJW Navorsing
    Krugersdorp, 1739, South Africa
  • I Engelbrecht Research
    Lyttleton, 0157, South Africa
  • Syzygy Clinical Research; Unit 3 to 7
    Pretoria Gauteng Province, 0087, South Africa
  • Jongaie Research
    Pretoria-West, 0183, South Africa
  • Queenswood CTC
    Queenswood, 0121, South Africa
  • Wits Clinical Research
    Soweto, 2013, South Africa
  • Welkom Clinical Trial Centre
    Welkom, 9460, South Africa
  • Hospital Mutua de Terrassa; Servicio de Oncologia
    Terrassa, Barcelona 08221, Spain
  • Hospital Universitario Son Espases
    Palma de Mallorca, Islas Baleares 07010, Spain
  • Hospital San Pedro
    Logroño, LA Rioja 26006, Spain
  • Hospital de Galdakao
    Galdacao, Vizcaya 48960, Spain
  • Hospital del Mar
    Barcelona, 08003, Spain
  • Hospital Clinic de Barcelona
    Barcelona, 08036, Spain
  • Surrey Clinical Research Centre; University of Surrey
    Guildford, GU2 7XP, United Kingdom
  • Barts and the London NHS Trust.
    London, EC1A 7BE, United Kingdom
  • The James Cook University Hospital
    Middlesborough, TS4 3BW, United Kingdom
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 13, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02623322
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Dec 7, 2015
Start date
Oct 12, 2016
Primary completion
Nov 13, 2017
Completion
Nov 13, 2017
Results posted
Jan 8, 2019
Last update
Jan 8, 2019

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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