Phase 1 Study of PHIN-214 Safety and Dosage in Adults Aged 18-75 With Child-Pugh A and B Liver Cirrhosis

What this Trial Is About

Researchers are evaluating PHIN-214, a drug similar to terlipressin, in adults with Child-Pugh A and B cirrhosis. This study aims to understand the safety, tolerability, and how the body processes PHIN-214. Terlipressin is known to reduce portal hypertension and improve kidney function in cirrhotic patients, and PHIN-214 is designed to have similar effects when given under the skin. The study has two parts. In Part 1, participants will receive a single subcutaneous dose of PHIN-214 at increasing dose levels to check initial safety. In Part 2, participants will be trained to give themselves daily doses of PHIN-214 by injection at home for 28 days, with dose levels adjusted based on safety reviews. A Safety Committee oversees dose decisions throughout the study. Participants will undergo assessments to monitor safety, how the drug and its metabolite move through the body, and immune responses, over up to six weeks. Researchers will determine the maximum tolerated or optimal dose of PHIN-214. The study includes careful health monitoring and regular evaluations to gather detailed information about the drugs effects in adults aged 18 to 75 with liver cirrhosis.

Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics