A PHASE I, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF HIGH DOSE MHAA4549A IN HEALTHY VOLUNTEERS

Genentech, Inc.1 site in 1 country14 target enrollmentNovember 3, 2014

ConditionsHealthy Volunteer

InterventionsMHAA4549A Placebo

DrugsMHAA4549A Placebo

Overview

Phase: Phase 1
Intervention: MHAA4549A
Conditions: Healthy Volunteer
Sponsor: Genentech, Inc.
Enrollment: 14
Locations: 1
Primary Endpoint: Changes in vital signs during and following MHAA4549A administration
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of two, single intravenous (IV) high doses of MHAA4549A as compared to placebo when administered to healthy volunteers.

Registry

clinicaltrials.gov

Start Date

November 3, 2014

End Date

March 13, 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 years and older
•Body mass index (BMI) between 18 and 32 kg/m2, inclusive
•Weight 40 - 100 kg
•In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations
•Willing to use acceptable contraceptive measures as defined by the protocol
•Agreeable to, and deemed able to by the investigator, to comply with the requirements of the study, including the follow-up period
•Willing to abstain from the use of drugs of abuse while enrolled in the study

Exclusion Criteria

•History or clinically significant manifestations of disorders
•History of acute allergic reaction or drug allergies
•History or presence of an abnormal ECG
•History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit
•History of significant drug abuse within 1 year prior to screening
•Current tobacco smokers
•Positive drug screen at screening or at check-in
•Positive pregnancy test result at screening or Day -1 or breast feeding during the study
•Males who have a pregnant female partner
•Donation of plasma within 7 days prior to study drug administration

Arms & Interventions

MHAA4549A higher dose

Intervention: MHAA4549A

MHAA4549A lower dose

Intervention: MHAA4549A

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Changes in vital signs during and following MHAA4549A administration

Time Frame: From baseline to end of study, up to 120 days

Incidence and nature of adverse events (AEs)

Time Frame: Until study discontinuation/termination, up to 120 days

Changes in ECG findings during and following MHAA4549A administration

Time Frame: From baseline to end of study, up to 120 days

Severity of AEs

Time Frame: Until study discontinuation/termination, up to 120 days

Secondary Outcomes

Pharmacokinetics (composite outcome measure): parameters derived from the nasal and serum concentration-time profile of MHAA4549A (area under the concentration-time curve [AUC], Cmax, tmax, clearance, Vss, half-life (t1/2), mean residence time)(Up to 120 days)