- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01980966
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
Intervention / Treatment
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
-
-
-
London, United Kingdom, NW1 0NH
- Retroscreen Ltd
-
-
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.
General Publications
- McBride JM, Lim JJ, Burgess T, Deng R, Derby MA, Maia M, Horn P, Siddiqui O, Sheinson D, Chen-Harris H, Newton EM, Fillos D, Nazzal D, Rosenberger CM, Ohlson MB, Lambkin-Williams R, Fathi H, Harris JM, Tavel JA. Phase 2 Randomized Trial of the Safety and Efficacy of MHAA4549A, a Broadly Neutralizing Monoclonal Antibody, in a Human Influenza A Virus Challenge Model. Antimicrob Agents Chemother. 2017 Oct 24;61(11):e01154-17. doi: 10.1128/AAC.01154-17. Print 2017 Nov.
- Deng R, Lee AP, Maia M, Lim JJ, Burgess T, Horn P, Derby MA, Newton E, Tavel JA, Hanley WD. Pharmacokinetics of MHAA4549A, an Anti-Influenza A Monoclonal Antibody, in Healthy Subjects Challenged with Influenza A Virus in a Phase IIa Randomized Trial. Clin Pharmacokinet. 2018 Mar;57(3):367-377. doi: 10.1007/s40262-017-0564-y.
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
Additional Relevant MeSH Terms
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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