A Phase 1b/2 Single and Multiple Dose Study to Assess the Safety, Tolerability, Clinical Activity, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Participants With Hereditary Angioedema (The ALPHA-STAR Trial)
Status: Completed
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The goal of this clinical trial is to test the drug STAR-0215 in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of STAR-0215, and two other groups will get 2 doses of STAR-0215. Researchers will study the effects of STAR-0215 in participants with HAE as this is the first time that the drug has been given to participants with HAE.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Documented diagnosis of HAE (type I or II). The following must be met:
• a. Documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria).
• Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.
Locations
United States
Alabama
Allervie Clinical Research
Birmingham
Arkansas
Allergy & Asthma Clinic of Northwest Arkansas
Bentonville
Acuro Research, Inc.
Little Rock
Arizona
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD.
Scottsdale
California
UC San Diego US HAEA Angioedema Center
San Diego
Raffi Tachdjian MD, Inc
Santa Monica
Allergy & Asthma Clinical Research
Walnut Creek
Massachusetts
Massachusetts General Hospital
Boston
Maryland
Institute for Asthma and Allergy, PC
Chevy Chase
Missouri
Washington University School of Medicine
St Louis
Ohio
Optimed Research
Columbus
Pennsylvania
Penn State Health Milton S. Hershey Medical Center
Hershey
Texas
AARA Research Center
Dallas
Other Locations
Bulgaria
Diagnostical Consultative Center Convex Ltd.
Sofia
Canada
University of Alberta
Edmonton
Ottawa Allergy Research Corporation
Ottawa
Germany
Charité Universitätsmedizin Berlin
Berlin
United Kingdom
Addenbrooke's Hospital
Cambridge
St. James's Hospital
Leeds
Time Frame
Start Date:2023-02-21
Completion Date:2025-03-13
Participants
Target number of participants:29
Treatments
Experimental: Cohort 1 - Single Dose
Participants will receive 1 dose of STAR-0215.
Experimental: Cohort 2 - Multiple Dose
Participants will receive 2 doses of STAR-0215 administered 3 months apart.
Experimental: Cohort 3 - Multiple Dose
Participants will receive 2 doses of STAR-0215 administered 1 month apart.