A Study of MHAA4549A to Assess Safety And Pharmacokinetics in Healthy Volunteers
NCT ID: NCT01877785
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2013-07-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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MHAA4549A Arm
MHAA4549A
Single-ascending dose of MHAA4549A
Placebo Arm
Placebo
Placebo to MHAA4549A
Interventions
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MHAA4549A
Single-ascending dose of MHAA4549A
Placebo
Placebo to MHAA4549A
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 18 and 32 kg/m2, inclusive
* Weight 40 to 100 kg
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
* Clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor
* Volunteers agree to use acceptable contraceptive measures
Exclusion Criteria
* History of anaphylaxis, hypersensitivity or drug allergies
* History or presence of an abnormal ECG
* History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit
* History of significant drug abuse within 1 year prior to screening
* Current tobacco smokers
* Positive drug screen at screening or at check-in
* Positive pregnancy test result at screening or Day -1 or breast feeding during the study
18 Years
ALL
Yes
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Québec, Quebec, Canada
Countries
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References
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Lim JJ, Deng R, Derby MA, Larouche R, Horn P, Anderson M, Maia M, Carrier S, Pelletier I, Burgess T, Kulkarni P, Newton E, Tavel JA. Two Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Studies To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza A Virus Monoclonal Antibody, MHAA4549A, in Healthy Volunteers. Antimicrob Agents Chemother. 2016 Aug 22;60(9):5437-44. doi: 10.1128/AAC.00607-16. Print 2016 Sep.
Other Identifiers
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GV28916
Identifier Type: -
Identifier Source: org_study_id