Treatment of Influenza MedDRA version: 20.1 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000004862 MedDRA version: 20.0 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 100000004862 MedDRA version: 20.0 Level: LLT
Conditions
Interventions
Product Name: MHAA4549A
Product Code: MHAA4549A/RO6876802
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: n.a.
Sponsors
Genentech Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - In good health with no history of major medical conditions from medical history, physical examination and routine laboratory tests - Male subjects and women of child-bearing potential must use effective contraception as defined by protocol, starting at entry to quarantine and continuing until Day 120 follow-up visit - Sero-suitable for challenge virus Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Women who have been pregnant within 6 months prior to the study, or who have been breastfeeding within 3 months prior to the study, or who have a positive pregnancy test at any point in the study - Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the CI - Abnormal pulmonary function evidenced by clinically significant abnormalities in spirometry - History of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung disease of any etiology. A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment. - History suggestive of respiratory infection within 14 days prior to admission to the unit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the reduction in AUC of virus load from the nasopharyngeal mucosa in the MHAA4549A treatment group compared to placebo;Secondary Objective: To evaluate safety, efficacy and pharmacokinetics; Primary end point(s): Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR) ; Timepoint(s) of evaluation of this end point: 8 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Safety: Incidence of adverse events 2) Safety: Change in lung function 3) Safety: Incidence of anti-therapeutic antibodies (ATAs) 4) Pharmacokinetics: Area under the concentration-time curve 5) AUC of nasopharyngeal viral load, as measured by cell culture 6) Peak viral load (qPCR and cell culture) 7) Duration of viral shedding ; Timepoint(s) of evaluation of this end point: 1) 120 days 2) from pre-challenge to Day 29 3) 120 days 4) 8 days 5) 8 days 6) 8 days 7) 8 days | — |
Countries
United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
GENENTECH, Inc. c/o F.Hoffmann-La Roche Ltd
Outcome results
None listed