Status:
COMPLETED
A Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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) admin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00997919
Start Date
October 1 2009
End Date
February 1 2010
Last Update
May 30 2017
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