Status:
COMPLETED
The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of 60 subjects. The study examined the tolerability of omalizumab and omalizumab excipients in two successive ...
Eligibility Criteria
Inclusion
- (Applicable to healthy subjects only) Healthy subjects not taking any regular prescription medication, without history of allergy, and considered healthy by the physician
- (Applicable to asthma patients only) Patients with atopic asthma diagnosed by a physician with asthma and history of positive skin test(s)
- Physical examination findings within normal limits
- Body mass index (BMI) between 18 and 30, inclusive
Exclusion
- Pregnancy and lactation
- Current or previous treatment with a biologic agent (e.g., monoclonal antibody)
- Concurrent disease or condition that would interfere, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to individuals in this study
- History or symptoms of significant psychiatric disease, including but not limited to, depression, schizophrenia, etc.
- History of drug abuse
- Participation in an investigational drug or device trial within the last 30 days prior to screening
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00777764
Start Date
August 1 2008
End Date
April 1 2009
Last Update
June 14 2017
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