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

May 25, 2017 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: B
Drug: MABT5102A
single SC dose
Drug: MABT5102A
single IV dose
EXPERIMENTAL: A
Drug: MABT5102A
single SC dose
Drug: MABT5102A
single IV dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety (adverse events, laboratory abnormalities, physical and neurological examination findings, vital signs, electrocardiogram (ECG) results)
Time Frame: Until study discontinuation
Until study discontinuation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2009

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

October 19, 2009

First Submitted That Met QC Criteria

October 19, 2009

First Posted (ESTIMATE)

October 20, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABE4662g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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