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