Healthy Volunteer
Conditions
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.
Interventions
DRUGMHAA4549A
Single-ascending dose of MHAA4549A
DRUGPlacebo
Placebo to MHAA4549A
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events | 120 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of anti-therapeutic antibodies | 120 days |
| Pharmacokinetics: Serum concentration-time profile of MHAA4549A | Pre-dose on day 1 to day 120 post-dose |
Countries
Canada
Outcome results
None listed