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

Genentech, Inc.0 sites22 target enrollmentOctober 2009

ConditionsHealthy Volunteer

InterventionsMABT5102A

DrugsMABT5102A

Overview

Phase: Phase 1
Intervention: MABT5102A
Conditions: Healthy Volunteer
Sponsor: Genentech, Inc.
Enrollment: 22
Primary Endpoint: Safety (adverse events, laboratory abnormalities, physical and neurological examination findings, vital signs, electrocardiogram (ECG) results)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

February 2010

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

A

Intervention: MABT5102A

B

Intervention: MABT5102A

Outcomes

Primary Outcomes

Safety (adverse events, laboratory abnormalities, physical and neurological examination findings, vital signs, electrocardiogram (ECG) results)

Time Frame: Until study discontinuation

Secondary Outcomes

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