Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2012-03-31
2012-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MCAF5352A
MCAF5352A
Multiple ascending doses
Placebo
Placebo
Matching MCAF5352A, multiple doses
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MCAF5352A
Multiple ascending doses
Placebo
Matching MCAF5352A, multiple doses
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects in good health as determined by screening medical history, physical examination, vital signs, 12-lead ECG and laboratory tests
* Body weight between 45 kg and 110 kg
* Female subjects must be willing to use two effective methods of contraception from screening to a minimum of 4 months after the last dose of study drug
Exclusion Criteria
* Positive for hepatitis B, hepatitis C or HIV infection
* History of significant chronic or recurrent infections
* History of clinically significant drug allergy and/or a known hypersensitivity to protein therapeutics or formulation components or a related drug
* History of alcohol or drug abuse within 12 months prior to Day 1, or evidence of such abuse
* Subjects who have previously received the study drug
* Participation in a clinical trial within 4 weeks prior to Day 1 or use of any experimental or biologic therapy within 12 weeks prior to Day 1 or within 5 half-lives of the product, whichever is greater
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Québec, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GA28006
Identifier Type: -
Identifier Source: org_study_id