Clinical trial NCT02623322: A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza A
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-07
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline to Day 100
Secondary outcomes:
measure: Percentage of Participants Requiring Hospitalization for Influenza-Related Complications
timeFrame: Baseline to Day 100
measure: Duration of Hospitalization for Influenza-Related Complications
timeFrame: Baseline to Day 100
measure: Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections
timeFrame: Baseline to Day 100
measure: Percentage of Participants With Complications of Influenza
timeFrame: Baseline to Day 100
measure: Percentage of Participants With Influenza A Relapse/Reinfection
timeFrame: Baseline to Day 100
measure: Area Under the Concentration-Time Curve (AUC) of MHAA4549A
timeFrame: 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)
measure: Maximum Serum Concentration (Cmax) of MHAA4549A
timeFrame: 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)
measure: Time to Alleviation of Symptoms of Influenza A Infection
timeFrame: Baseline to Day 14
measure: Percentage of Participants With Influenza-Related Deaths
timeFrame: Baseline to Day 100
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center LLC
state: Alabama
city: Costa Mesa
country: United States
facility: WCCT Global, LLC
state: California
city: Fountain Valley
country: United States
facility: Lalla-Reddy Medical Corporation
state: California
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: Doral
country: United States
facility: Integrity Clinical Research
state: Florida
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: The Community Research Of South Florida
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Miami
country: United States
facility: South Florida Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Oceane7 Clinical Research
state: Florida
city: Saint Cloud
country: United States
facility: Central Florida Internists
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Trinity
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Wichita
country: United States
facility: Professional Research Network of Kansas
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Hazard
country: United States
facility: Kentucky Lung Clinic
state: Kentucky
city: Metairie
country: United States
facility: MedPharmics
state: Louisiana
city: Opelousas
country: United States
facility: Acadiana Medicine Clinic
state: Louisiana
city: Annapolis
country: United States
facility: Anne Arundel Medical Center; Anne Arundel Health System
state: Maryland
city: Worcester
country: United States
facility: UMASS Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
city: Detroit
country: United States
facility: Sinai Grace Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group
state: Montana
city: La Vista
country: United States
facility: Barrett Clinic, P.C.
state: Nebraska
city: Princeton
country: United States
facility: Global Medical Institutes, LLC
state: New Jersey
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Providence
country: United States
facility: Center For Medical Research LLC
state: Rhode Island
city: Boiling Springs
country: United States
facility: Emergency MD
state: South Carolina
city: Franklin
country: United States
facility: HCCA Clinical Research Solutions
state: Tennessee
city: Knoxville
country: United States
facility: Clinical Research Solutions PC
state: Tennessee
city: Smyrna
country: United States
facility: Clinical Research Solutions, LLC
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Houston
country: United States
facility: Centex Studies
state: Texas
city: Pharr
country: United States
facility: Centex Studies
state: Texas
city: Vancouver
country: Canada
facility: Manna Research Vancouver
state: British Columbia
city: Moncton
country: Canada
facility: Moncton Hospital
state: New Brunswick
city: Toronto
country: Canada
facility: Manna Research
state: Ontario
city: Gatineau
country: Canada
facility: Q and T Research
state: Quebec
city: Quebec
country: Canada
facility: inVentiv Health Clinique
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon-si,
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
city: Auckland
country: New Zealand
facility: Henderson Medical Centre
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials
city: Dunedin
country: New Zealand
facility: RMC Medical Research Ltd
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Centurion
country: South Africa
facility: Johese Clinical Research
city: Durban
country: South Africa
facility: Durban International Clinical Research Site
city: Durban
country: South Africa
facility: Vawda Z Private Practice
city: Durban
country: South Africa
facility: Dr Peter John Sebastian; Dr PJ Sebastian
city: Groenkloof
country: South Africa
facility: Into Research; Life Groenkloof Hospital Medical Centre
city: Johannesburg
country: South Africa
facility: Worthwhile Clinical Trials
city: Johannesburg
country: South Africa
facility: Newtown Clinical Research
city: Kempton Park
country: South Africa
facility: Clinresco Centres (Pty) Ltd
city: Kempton Park
country: South Africa
facility: Peermed Clinical Trial Centre
city: Klerksdorp
country: South Africa
facility: Klerksdorp /Tshepong Hospital Complex
city: Krugersdorp
country: South Africa
facility: DJW Navorsing
city: Lyttleton
country: South Africa
facility: I Engelbrecht Research
city: Pretoria Gauteng Province
country: South Africa
facility: Syzygy Clinical Research; Unit 3 to 7
city: Pretoria-West
country: South Africa
facility: Jongaie Research
city: Queenswood
country: South Africa
facility: Queenswood CTC
city: Soweto
country: South Africa
facility: Wits Clinical Research
city: Welkom
country: South Africa
facility: Welkom Clinical Trial Centre
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa; Servicio de Oncologia
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Logroño
country: Spain
facility: Hospital San Pedro
state: LA Rioja
city: Galdacao
country: Spain
facility: Hospital de Galdakao
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Guildford
country: United Kingdom
facility: Surrey Clinical Research Centre; University of Surrey
city: London
country: United Kingdom
facility: Barts and the London NHS Trust.
city: Middlesborough
country: United Kingdom
facility: The James Cook University Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: