A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study in Healthy Volunteers to Evaluate the Efficacy and Safety of MHAA4549A in an Influenza Challenge Model

Genentech, Inc.1 site in 1 country101 target enrollmentNovember 25, 2013

ConditionsHealthy Volunteer

InterventionsPlacebo MHAA549A oseltamivir [Tamiflu]

DrugsMHAA549A Placebo oseltamivir [Tamiflu]

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Healthy Volunteer
Sponsor: Genentech, Inc.
Enrollment: 101
Locations: 1
Primary Endpoint: Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 25, 2013

End Date

June 19, 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility 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

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

Arms & Interventions

Placebo

Intervention: Placebo

MHAA4549A

Intervention: MHAA549A

Tamiflu

Intervention: oseltamivir [Tamiflu]

Outcomes

Primary Outcomes

Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR)

Time Frame: 8 days

Secondary Outcomes

Safety: Incidence of adverse events(120 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)
AUC of nasopharyngeal viral load, as measured by cell culture(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)