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Completed

NCT Number: NCT01980966

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retroscreen Ltd

London, NW1 0NH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MHAA549A

Drug

IV dose

Placebo

Drug

IV dose

oseltamivir [Tamiflu]

Drug

Orally b.i.d, 5 days

Primary outcomes

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

    Time frame: 8 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 11, 2013
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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