A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model
Phase 2
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT01980966
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of MHAA4549A in healthy volunteers in an influenza challenge model. Subjects will be intranasally oculated with the challenge virus and will be randomly assigned to receive a intravenous dose of either MHAA4549A or placebo. In the stage 5 cohort, subjects will be randomly assigned to receive doses of MHAA4549A or placebo or Tamiflu (oseltamivir) orally twice daily for 5 days. All subjects in all cohorts may take Tamiflu twice daily from Day 7 to Day 11.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MHAA4549A MHAA549A - Placebo Placebo - Tamiflu oseltamivir [Tamiflu] -
- Primary Outcome Measures
Name Time Method Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR) 8 days
- Secondary Outcome Measures
Name Time Method Safety: Incidence of adverse events 120 days AUC of nasopharyngeal viral load, as measured by cell culture 8 days Safety: Change in lung function from pre-challenge to Day 29 Safety: Incidence of anti-therapeutic antibodies (ATAs) 120 days Pharmacokinetics: Area under the concentration-time curve 8 days Peak viral load (qPCR and cell culture) 8 days Duration of viral shedding 8 days Duration of Grade 2 or worse symptoms (from first occurrence of any Grade >2 symptom to last occurrence of any Grade >2 symptom) 8 days Peak/AUC of composite symptoms 8 days
Trial Locations
- Locations (1)
Retroscreen Ltd
🇬🇧London, United Kingdom