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A Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00997919
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief Summary:
This Phase I, single-dose, randomized, parallel-group, open-label study will evaluate the safety, tolerability, and pharmacokinetics of MABT5102A following subcutaneous (SC) and intravenous (IV) administration in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: MABT5102A Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Single-Dose, Randomized, Parallel-Group, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers
Actual Study Start Date : October 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: MABT5102A
single SC dose
Experimental: B Drug: MABT5102A
single IV dose


Outcome Measures
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Primary Outcome Measures :
  1. Safety (adverse events, laboratory abnormalities, physical and neurological examination findings, vital signs, electrocardiogram (ECG) results) [ Time Frame: Until study discontinuation ]

Secondary Outcome Measures :
  1. Pharmacokinetic/Pharmacodynamic (area under the concentration-time curve, volume of distribution, clearance [CL] and apparent CL, terminal half-life) [ Time Frame: Until study discontinuation ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Male subjects aged 18-50 years and female subjects aged 18-50 years who are not of childbearing potential and who are in good general health at the screening visit
  • 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

  • Female subjects with reproductive potential.
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997919


Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Robert Paul, Ph.D., M.D. Genentech, Inc.
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00997919    
Other Study ID Numbers: ABE4662g
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs