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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02623322




Registration number
NCT02623322
Ethics application status
Date submitted
3/12/2015
Date registered
7/12/2015
Date last updated
8/01/2019

Titles & IDs
Public title
A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults
Scientific 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
Secondary ID [1] 0 0
2016-000425-40
Secondary ID [2] 0 0
GV29893
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza A 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MHAA4549A
Treatment: Drugs - Placebo

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

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

Placebo Comparator: Placebo - Participants will receive single-dose placebo by IV administration.


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

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline to Day 100
Secondary outcome [1] 0 0
Percentage of Participants Requiring Hospitalization for Influenza-Related Complications
Timepoint [1] 0 0
Baseline to Day 100
Secondary outcome [2] 0 0
Duration of Hospitalization for Influenza-Related Complications
Timepoint [2] 0 0
Baseline to Day 100
Secondary outcome [3] 0 0
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."
Timepoint [3] 0 0
Baseline to Day 100
Secondary outcome [4] 0 0
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."
Timepoint [4] 0 0
Baseline to Day 100
Secondary outcome [5] 0 0
Percentage of Participants With Influenza A Relapse/Reinfection
Timepoint [5] 0 0
Baseline to Day 100
Secondary outcome [6] 0 0
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).
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
Maximum Serum Concentration (Cmax) of MHAA4549A
Timepoint [7] 0 0
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)
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline to Day 14
Secondary outcome [9] 0 0
Percentage of Participants With Influenza-Related Deaths
Timepoint [9] 0 0
Baseline to Day 100

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Florida
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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Montana
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Nebraska
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New Jersey
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North Carolina
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Canada
State/province [20] 0 0
British Columbia
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Canada
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Korea, Republic of
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Anyang-si
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Korea, Republic of
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Bucheon-si,
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Korea, Republic of
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Wonju
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New Zealand
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Auckland
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New Zealand
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Dunedin
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New Zealand
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Tauranga
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South Africa
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Centurion
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South Africa
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Durban
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South Africa
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Groenkloof
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Kempton Park
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Klerksdorp
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Krugersdorp
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Lyttleton
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South Africa
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Pretoria Gauteng Province
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South Africa
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Pretoria-West
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South Africa
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Queenswood
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Soweto
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Welkom
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Spain
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Barcelona
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Spain
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Islas Baleares
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Spain
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LA Rioja
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Spain
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Vizcaya
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United Kingdom
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Guildford
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United Kingdom
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London
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United Kingdom
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Middlesborough

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02623322
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications