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A Study of Navenibart (STAR-0215) in Participants With Hereditary Angioedema
Sponsor: Astria Therapeutics, Inc.
Summary
The goal of this clinical trial is to test the drug navenibart in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of navenibart, and 2 other groups will get 2 doses of navenibart. Researchers will study the effects of navenibart in participants with HAE as this is the first time that the drug has been given to participants with HAE.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
29
Start Date
2023-02-21
Completion Date
2025-03-13
Last Updated
2026-05-08
Healthy Volunteers
No
Conditions
Interventions
Navenibart
Navenibart will be administered as a subcutaneous bolus injection.
Locations (20)
Allervie Clinical Research
Birmingham, Alabama, United States
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD.
Scottsdale, Arizona, United States
Allergy & Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas, United States
Acuro Research, Inc.
Little Rock, Arkansas, United States
UC San Diego US HAEA Angioedema Center
San Diego, California, United States
Raffi Tachdjian MD, Inc
Santa Monica, California, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, United States
Institute for Asthma and Allergy, PC
Chevy Chase, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Optimed Research
Columbus, Ohio, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
AARA Research Center
Dallas, Texas, United States
Diagnostical Consultative Center Convex Ltd.
Sofia, Bulgaria
University of Alberta
Edmonton, Alberta, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada
Institute of Clinical Immunology/Allergology, Faculty Hospital
Hradec Králové, Czechia
Charité Universitätsmedizin Berlin
Berlin, Germany
Addenbrooke's Hospital
Cambridge, United Kingdom
St. James's Hospital
Leeds, United Kingdom