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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01980966
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: MHAA549A Drug: Placebo Drug: oseltamivir [Tamiflu] Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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
Actual Study Start Date : November 25, 2013
Actual Primary Completion Date : June 19, 2014
Actual Study Completion Date : June 19, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oseltamivir

Arm Intervention/treatment
Experimental: MHAA4549A Drug: MHAA549A
IV dose

Placebo Comparator: Placebo Drug: Placebo
IV dose

Active Comparator: Tamiflu Drug: oseltamivir [Tamiflu]
Orally b.i.d, 5 days




Primary Outcome Measures :
  1. Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR) [ Time Frame: 8 days ]

Secondary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: 120 days ]
  2. Safety: Change in lung function [ Time Frame: from pre-challenge to Day 29 ]
  3. Safety: Incidence of anti-therapeutic antibodies (ATAs) [ Time Frame: 120 days ]
  4. Pharmacokinetics: Area under the concentration-time curve [ Time Frame: 8 days ]
  5. AUC of nasopharyngeal viral load, as measured by cell culture [ Time Frame: 8 days ]
  6. Peak viral load (qPCR and cell culture) [ Time Frame: 8 days ]
  7. Duration of viral shedding [ Time Frame: 8 days ]
  8. Duration of Grade 2 or worse symptoms (from first occurrence of any Grade >2 symptom to last occurrence of any Grade >2 symptom) [ Time Frame: 8 days ]
  9. Peak/AUC of composite symptoms [ Time Frame: 8 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980966


Locations
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United Kingdom
Retroscreen Ltd
London, United Kingdom, NW1 0NH
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01980966    
Other Study ID Numbers: GV28985
2013-001983-52 ( EudraCT Number )
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action