A Study of the Safety, Tolerability, Pharmacokinetics, an... | NCT00997919

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

NCT00997919

Sponsor

Genentech, Inc.

Status

Completed

Last Update Posted

May 30, 2017Actual

Enrollment

22Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

MABT5102A
MABT5102A

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009Actual

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Oct 19, 2009

First Submission Date that Met QC Criteria

Oct 19, 2009

First Posted Date

Oct 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2017

Last Update Posted Date

May 30, 2017Actual

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Label	Type	Description	Intervention Names
A	Experimental		Drug: MABT5102A
B	Experimental		Drug: MABT5102A

Name	Type	Description	Arm Group Labels	Other Names
MABT5102A	Drug	single SC dose	A
MABT5102A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided