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

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: MHAA4549A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01877785

GV28916

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

21 participants in 2 patient groups, including a placebo group

MHAA4549A Arm

Experimental group

Treatment:

Drug: MHAA4549A

Placebo Arm

Placebo Comparator group

Treatment:

Drug: Placebo