Initial Results from a Phase 1 Single Ascending Dose Clinical Trial of STAR-0215, an Investigational Long-Acting Monoclonal Antibody Plasma Kallikrein Inhibitor for Hereditary Angioedema (HAE), in Healthy Subjects Followed for at Least 3 Months

Abstract

The majority of HAE cases are caused by C1-INH deficiencies, resulting in uncontrolled activation of plasma kallikrein. STAR-0215 is an investigational humanized IgG1kappa monoclonal antibody with potent and durable (≥3 month) reduction of plasma kallikrein activity demonstrated in cynomolgus monkeys. This Phase 1 trial (NCT05477160) is assessing safety and the pharmacokinetic (PK) and pharmacodynamic (PD) activities that support subcutaneous administration of STAR-0215 to achieve potentially robust and durable suppression of HAE attacks for 3 months or longer.