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History of Changes for Study: NCT00997919
A Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers
Latest version (submitted May 25, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 19, 2009 None (earliest Version on record)
2 May 19, 2010 Recruitment Status, Study Status, Contacts/Locations and Conditions
3 November 11, 2010 Study Status and Sponsor/Collaborators
4 May 12, 2017 Study Status, Sponsor/Collaborators and Study Design
5 May 25, 2017 Study Status
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Study NCT00997919
Submitted Date:  October 19, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: ABE4662g
Brief Title: A Study of the Safety, Tolerability, Pharmacokinetics, and Bioavailability of IV and SC MABT5102A in Healthy Volunteers
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
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2009
Overall Status: Not yet recruiting
Study Start: November 2009
Primary Completion: May 2010 [Anticipated]
Study Completion:
First Submitted: October 19, 2009
First Submitted that
Met QC Criteria:
October 19, 2009
First Posted: October 20, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 19, 2009
Last Update Posted: October 20, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Genentech, Inc.
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Healthy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 22 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: A Drug: MABT5102A
single SC dose
Experimental: B Drug: MABT5102A
single IV dose
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Shane Smith
Telephone: 650-467-8973
Email: smith.shane_oncology@gene.com
Study Officials: Robert Paul, Ph.D., M.D.
Study Director
Genentech, Inc.
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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