Status:
COMPLETED
A Study of MHAA4549A to Assess Safety And Pharmacokinetics in Healthy Volunteers
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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. Voluntee...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01877785
Start Date
July 1 2013
End Date
November 1 2013
Last Update
November 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Québec, Quebec, Canada, G1P 0A2