A Study of MHAA4549A to Assess Safety And Pharmacokinetics in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Placebo; Drug: MHAA4549A

• Registration Number: NCT01877785
• Lead Sponsor: Genentech, Inc.

Brief Summary

This randomized, double-blind, placebo-controlled, single-ascending dose study will assess the safety, tolerability and pharmacokinetics of ascending doses of MHAA4549A in healthy volunteers. Volunteers will be randomized to receive a single dose of MHAA4549A or matching placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-14
• Study Start: 2013-07
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Healthy volunteers
• Body mass index (BMI) between 18 and 32 kg/m2, inclusive
• Weight 40 to 100 kg
• In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
• Clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor
• Volunteers agree to use acceptable contraceptive measures

Exclusion Criteria

• History or clinically significant manifestations of disorders
• History of anaphylaxis, hypersensitivity 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo	-
MHAA4549A Arm	MHAA4549A	-

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	120 days

Secondary Outcome Measures

Name	Time	Method
Incidence of anti-therapeutic antibodies	120 days
Pharmacokinetics: Serum concentration-time profile of MHAA4549A	Pre-dose on day 1 to day 120 post-dose