The objectives of the study are to: 1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema 2. Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection 3. Assess the immunogenicity of CINRYZE following subcutaneous administration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
26
C1 esterase inhibitor (human)
Allergy, Asthma and Immunology Associates
Scottsdale, Arizona, United States
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States
Family Allergy and Asthma Center
Atlanta, Georgia, United States
Institute for Asthma and Allergy
Chevy Chase, Maryland, United States
Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.
Time frame: 18 days in each treatment period
Mean Change C1 Inhibitor (C1INH)
Mean Change in Baseline in Observed Plasma Concentration of C1 Inhibitor (C1INH) Antigen. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.
Time frame: 18 days in each treatment period
Mean Change C4 Compliment
Mean Change in Baseline in Observed Plasma Concentration of C4 Compliment. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.
Time frame: 18 days in each treatment period
Number of Participants With C1 Inhibitor (INH) Antibodies
Time frame: 18 days in each treatment period
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Allergy, Asthma and Dermatology Research Center
Lake Oswego, Oregon, United States
AARA Research Center
Dallas, Texas, United States
Marycliff Allergy Specialists
Spokane, Washington, United States