Phase 1b2a Study of Oral CRN04894 for Safety and Body Response in Adults with ACTH-Dependent Cushings Syndrome

What this Trial Is About

Researchers are evaluating CRN04894, an adrenocorticotropic hormone ACTH receptor antagonist, in adults with ACTH-dependent Cushings syndrome, including Cushings disease and Ectopic ACTH Syndrome EAS. This Phase 1b2a open-label study aims to explore the safety, tolerability, pharmacokinetics PK, and pharmacodynamic biomarker responses of CRN04894 in this patient population. The study is a first-in-disease, multiple-ascending dose exploratory trial to better understand how the drug behaves and affects the condition. Participants will receive oral doses of atumelnant CRN04894 once daily for either 10 or 14 days in a sequential, open-label format. The treatment periods are followed by a 4-day washout phase after the 10-day dosing group. The study includes fixed-dose cohorts and monitors participants throughout these periods to assess the drugs impact on the disease and the body. During the study, participants will undergo monitoring for safety, including treatment-emergent adverse events, adrenal insufficiency, and laboratory test findings, all assessed up to Day 15. Pharmacokinetic measures include maximum plasma concentration, time to reach this concentration, and plasma exposure over time. Additionally, early morning serum cortisol levels will be tracked to evaluate changes from baseline. The total participation involves dosing and follow-up assessments to collect this comprehensive data.

A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome