A Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers
NCT ID: NCT00997919
Last Updated: 2017-05-30
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
22 participants
INTERVENTIONAL
2009-10-31
2010-02-28
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
TREATMENT
NONE
Study Groups
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A
MABT5102A
single SC dose
B
MABT5102A
single IV dose
Interventions
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MABT5102A
single SC dose
MABT5102A
single IV dose
Eligibility Criteria
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Inclusion Criteria
* Body weight between 50 and 100 kg
* For male subjects of reproductive potential, a reliable means of contraception must be used (e.g., abstinence or a condom) for the duration of the study
Exclusion Criteria
* Subjects with evidence of clinically significant neurologic, psychiatric, hepatic, renal, hematologic, pulmonary, respiratory, immunologic system abnormalities, acute infection, or other unstable medical disease
* Subjects with any malignancy (with the exception of completely excised basal cell or squamous cell carcinoma of the skin)
* History of alcohol, drug, or substance abuse within 6 months prior to randomization that, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study
* Past history of seizures, with the exception of childhood febrile seizures
* Clinically significant laboratory or ECG abnormalities
* Hospitalization during the 4 weeks prior to screening
18 Years
50 Years
ALL
Yes
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Paul, Ph.D., M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Other Identifiers
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ABE4662g
Identifier Type: -
Identifier Source: org_study_id
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