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

March 7, 2017 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
IV dose
EXPERIMENTAL: MHAA4549A
IV dose
ACTIVE_COMPARATOR: Tamiflu
Orally b.i.d, 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR)
Time Frame: 8 days
8 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: 120 days
120 days
Safety: Change in lung function
Time Frame: from pre-challenge to Day 29
from pre-challenge to Day 29
Safety: Incidence of anti-therapeutic antibodies (ATAs)
Time Frame: 120 days
120 days
Pharmacokinetics: Area under the concentration-time curve
Time Frame: 8 days
8 days
AUC of nasopharyngeal viral load, as measured by cell culture
Time Frame: 8 days
8 days
Peak viral load (qPCR and cell culture)
Time Frame: 8 days
8 days
Duration of viral shedding
Time Frame: 8 days
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)
Time Frame: 8 days
8 days
Peak/AUC of composite symptoms
Time Frame: 8 days
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 25, 2013

Primary Completion (ACTUAL)

June 19, 2014

Study Completion (ACTUAL)

June 19, 2014

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (ESTIMATE)

November 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • GV28985
  • 2013-001983-52 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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