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

• ClinicalTrials.gov Identifier: NCT00997919
• Recruitment Status: Completed
• First Posted: October 20, 2009
• Last Update Posted: May 30, 2017
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Tracking Information

• First Submitted Date: October 19, 2009
• First Posted Date: October 20, 2009
• Last Update Posted Date: May 30, 2017
• Actual Study Start Date: October 2009
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 19, 2009): Safety (adverse events, laboratory abnormalities, physical and neurological examination findings, vital signs, electrocardiogram (ECG) results) [ Time Frame: Until study discontinuation ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 19, 2009): Pharmacokinetic/Pharmacodynamic (area under the concentration-time curve, volume of distribution, clearance [CL] and apparent CL, terminal half-life) [ Time Frame: Until study discontinuation ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy Volunteer

Intervention

• Drug: MABT5102A
  single SC dose
• Drug: MABT5102A
  single IV dose

Study Arms

• Experimental: A
  Intervention: Drug: MABT5102A
• Experimental: B
  Intervention: Drug: MABT5102A

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 19, 2009): 22
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2010
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00997919
• Other Study ID Numbers: ABE4662g
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Genentech, Inc.
• Original Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
• Current Study Sponsor: Genentech, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Robert Paul, Ph.D., M.D.; Genentech, Inc.

• PRS Account: Genentech, Inc.
• Verification Date: May 2017