Status:
COMPLETED
A Study of High Dose MHAA4549A in Healthy Volunteers
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of two, single intravenous (IV) high doses of MHAA4549A as compared to plac...
Eligibility Criteria
Inclusion
- Age 18 years and older
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive
- Weight 40 - 100 kg
- In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations
- Willing to use acceptable contraceptive measures as defined by the protocol
- Agreeable to, and deemed able to by the investigator, to comply with the requirements of the study, including the follow-up period
- Willing to abstain from the use of drugs of abuse while enrolled in the study
Exclusion
- History or clinically significant manifestations of disorders
- History of acute allergic reaction 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
- Males who have a pregnant female partner
- Donation of plasma within 7 days prior to study drug administration
- Donation or loss of whole blood
- Receipt of blood products within 2 months before initiation of dosing on Day 1
- History of malignancy within 10 years of screening except completely excised basal cell carcinoma or squamous cell carcinoma of the skin
- History of severe systemic bacterial, fungal, or parasitic infections associated with more than two hospitalizations per year or more than two courses of intravenous (IV) antibiotics within 1 year
- Received oral antibiotics within 4 weeks before initiation of dosing on Day 1, or IV antibiotics within 8 weeks before initiation of dosing
- Hospitalization within 4 weeks before initiation of dosing on Day 1
- Use of any over the counter or prescription medications/products within 7 days prior to Day 1 and unwilling to abstain from the use of such drugs up until at least the Day 29 study visit, unless deemed acceptable by the investigator and Sponsor
- Participation in a clinical trial within 4 weeks
- Received any vaccine within 14 days prior to screening
- Positive blood test for chronic viral infections
Key Trial Info
Start Date :
November 3 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02284607
Start Date
November 3 2014
End Date
March 13 2015
Last Update
March 9 2017
Active Locations (1)
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1
inVentiv Health Clinique
Québec, Quebec, Canada, G1P 0A2