The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of multiple subcutaneous administrations of DX-2930 across a range of doses in HAE participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
Participants will receive SC injection of DX-2930 (a recombinant, Chinese hamster ovary \[CHO\] cell expressed, fully human immunoglobulin IgG1, kappa light chain, monoclonal antibody) once and followed by the second dose after 2 week into the upper arm.
Participants will receive matching placebo subcutaneously.
UC San Diego Health System - La Jolla
San Diego, California, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, United States
Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE)
A SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes: Death, Life-threatening experience, required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant disability or incapacity. Was a congenital anomaly or birth defect. Was considered to be an important medical event. An AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period.
Time frame: From Day 1 up to final follow-up (Day 123)
Maximum Plasma Concentration (Cmax)
Pharmacokinetic (PK) parameter Cmax data were reported.
Time frame: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120
Time to Maximum Plasma Concentration (Tmax)
PK parameter Tmax data were reported.
Time frame: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120
Area Under the Plasma Concentration-Time Curve (AUC)
PK paramenter AUC data were reported.
Time frame: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120
Apparent Clearance (CL/F)
PK parameter CL/F data were reported.
Time frame: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120
Apparent Volume of Distribution (Vd/F)
PK parameter Vd/F data were reported.
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University of South Florida Asthma, Allergy or Immunology Clinical Research Unit
Tampa, Florida, United States
Institute for Asthma & Allergy, PC
Chevy Chase, Maryland, United States
Massachusetts General Hospital Allergy Associates
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Winthrop-University Hospital, Clinical Trials Center
Mineola, New York, United States
Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center
New York, New York, United States
UC Physicians Company
Cincinnati, Ohio, United States
Baker Allergy, Asthma and Dermatology Research Center
Lake Oswego, Oregon, United States
...and 4 more locations
Time frame: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120
Terminal Elimination Half-Life (t1/2)
PK parameter t(1/2) data were reported.
Time frame: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120