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

Influenza A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623322
• Other study ID #: GV29893
• Secondary ID: 2016-000425-40
• Status: Completed
• Phase: Phase 2
• Start date: October 12, 2016
• Est. completion date: November 13, 2017

Study information

• Verified date: December 2018
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: November 13, 2017
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza A
• Influenza, Human

Intervention

Drug:
• MHAA4549A
MHAA4549A will be administered as a single dose by IV administration.
• Placebo
Placebo will be administered as a single dose by IV administration.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Korea, Republic of,  New Zealand,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Day 100
Secondary	Percentage of Participants Requiring Hospitalization for Influenza-Related Complications		Baseline to Day 100
Secondary	Duration of Hospitalization for Influenza-Related Complications		Baseline to Day 100
Secondary	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."	Baseline to Day 100
Secondary	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."	Baseline to Day 100
Secondary	Percentage of Participants With Influenza A Relapse/Reinfection		Baseline to Day 100
Secondary	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).	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	Maximum Serum Concentration (Cmax) of MHAA4549A		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	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.	Baseline to Day 14
Secondary	Percentage of Participants With Influenza-Related Deaths		Baseline to Day 100