The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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 cohorts of subjects, healthy volunteers and patients with allergic asthma without prior exposure to omalizumab, according to a skin test protocol, consisting of a prick skin test and/or intradermal test.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Histamine; Histamine phosphate; Omalizumab

Criteria

Inclusion Criteria:

• (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 Criteria:

• 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