A new study testing the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the experimental treatment STAR-0215 for hereditary angioedema (HAE) is now recruiting participants.
The phase 1a, single-center, randomized, double-blind, placebo-controlled, single-ascending dose, first-in-human study aims to recruit 24 healthy volunteers, aged 18 to 60 years, at Spaulding Clinical Research in West Bend, Wisconsin.
Participants will be randomized to receive 1 of 3 doses of STAR-0215 (100 mg, 300 mg, or 600 mg) or a placebo.
The primary outcome measure of the trial is the number of participants experiencing treatment-emergent adverse events. Secondary outcome measures are the serum concentration of STAR-0215, plasma levels of cleaved high-molecular-weight kininogen, and the number of participants with antidrug antibodies against STAR-0215.
Read more about the pathophysiology of HAE
STAR-0215 is a monoclonal antibody that inhibits plasma kallikrein to prevent HAE attacks. Experiments in cynomolgus monkeys have shown that the subcutaneous administration of STAR-0215 led to a rapid inhibition of plasma kallikrein and rapid and sustained cleavage of high-molecular-weight kininogen.
The trial is expected to be completed in June 2023, with preliminary results being available by the end of this year.
Astria Therapeutics announces initiation of phase 1a trial of STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein for treatment of hereditary angioedema. News release. Astria Therapeutics, Inc; August 4, 2022.
A study of STAR-0215 in healthy adult participants. ClinicalTrials.gov. July 28, 2022. Updated August 11, 2022. Accessed August 12, 2022.