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A Study of MHAA4549A in Healthy Volunteers in an Influenza Challenge Model

Information source: Genentech, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteer

Intervention: MHAA549A (Drug); Placebo (Drug); oseltamivir [Tamiflu] (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Genentech, Inc.

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Genentech, Inc.

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

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

Secondary outcome:

Safety: Incidence of adverse events

Safety: Change in lung function

Safety: Incidence of anti-therapeutic antibodies (ATAs)

Pharmacokinetics: Area under the concentration-time curve

AUC of nasopharyngeal viral load, as measured by cell culture

Peak viral load (qPCR and cell culture)

Duration of viral shedding

Duration of Grade 2 or worse symptoms (from first occurrence of any Grade >2 symptom to last occurrence of any Grade >2 symptom)

Peak/AUC of composite symptoms

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Locations and Contacts

London NW1 0NH, United Kingdom
Additional Information

Starting date: November 2013
Last updated: March 3, 2015

Page last updated: August 23, 2015

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