The ALPHA-STAR (Astria Long-Acting Prophylaxis for Hereditary Angioedema: STAR-0215) trial is a Phase 1b/2 proof-of-concept trial evaluating single and multiple doses of STAR-0215 in people living with HAE types I and II. The trial is expected to initiate in Q1 2023 and will take place at sites across the globe.
The trial will evaluate safety and tolerability, HAE attack rate, pharmacokinetics, pharmacodynamics, and quality of life in patients.
The trial will screen people with HAE types I and II who have had at least 4 attacks in the last year.
STAR-0215 is an investigational monoclonal antibody inhibitor of plasma kallikrein with the potential to provide long-acting attack prevention for HAE with subcutaneous dosing (an injection given in the fatty tissue just under your skin using a small needle) once every 3 months or less frequently.