Table of contents
Trial overview
The available study for Star-0215 was an interventional trial, which means researchers gave the study drug to participants and then measured the results.[1]
This trial studied adults with hereditary angioedema (HAE), a condition that causes repeated swelling episodes.[1]
The study was in Phase 1, an early research stage that usually focuses on safety and how the body responds to a treatment.[1]
Who participated
The trial included adults with Type I or Type II HAE.[1]
These are the two HAE types named in the study summary, so the trial was focused on people who already had this diagnosis.[1]
The study enrolled 62 participants in total.[1]
What was studied
The study aimed to assess the safety and tolerability of Star-0215 after subcutaneous use, meaning the drug was given under the skin.[1]
Researchers looked at both single doses and multiple doses of Star-0215.[1]
This helps show how people respond to the study drug over time, especially in an early trial.[1]
Main study endpoints
The main outcomes were incidence of adverse events, which means how often unwanted medical problems happened during the study.[1]
Other endpoints included changes in vital signs, ECG findings, physical examination findings, and clinical laboratory evaluations.[1]
These measures help researchers watch for safety signals and changes in health during the trial.[1]
Trial status and size
The study is listed as completed, which means the planned study activities and data collection are finished.[1]
The trial had a modest size, with 62 enrolled participants, which is typical for an early Phase 1 study.[1]
