NCT05490888

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

A Phase 1 Open Label Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PHIN-214 in Adults With Child Pugh A and B Cirrhosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: PharmaIN · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This 2-part study will evaluate PHIN-214 given as a single one-time dose (Part 1) and in multiple doses (given as daily doses for 28-days) (in Part 2). Specifically, this study evaluates PHIN-214, to determine the safety, tolerability, and pharmacokinetic effects of PHIN-214, and to establish the maximum tolerated dose or optimal beneficial dose in patients with Child Pugh A and B Cirrhosis.

Detailed description

PHIN-214 action has similar actions as another medication called "terlipressin or TERLIVAZ®." Terlipressin has been shown to reduce portal hypertension, improve renal function, and induce natriuresis in cirrhotic patients with ascites without hepatorenal syndrome (HRS). It is approved in several countries including the US for the treatment of bleeding esophageal varices and HRS type 1 and is usually administered using multiple IV doses given by bolus injections in the hospital. This study is an open label, first in human study of PHIN-214. PHIN-214 is a terlipressin derivative administered subcutaneously. It is a partial V1a agonist which is designed to reduce splanchnic blood pooling and portal hypertension. A resultant increase in systemic pressure and renal arterial pressure may increase kidney perfusion and creatinine clearance. This study will evaluate a single dose of PHIN-214 (in Part 1) and in Part 2, daily doses of PHIN-214 for up to 28-days (called multiple ascending doses) of PHIN-214 to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of PHIN-214 in subjects with advanced cirrhosis.

Conditions

• Cirrhosis, Liver
• Liver Fibrosis
• Ascites Hepatic

Interventions

Type	Name	Description
DRUG	PHIN-214 Subcutaneous injection	subcutaneous injection(s) with PHIN-214 terlipressin derivative

Timeline

• Start date: 2022-01-03
• Primary completion: 2026-05-31
• Completion: 2026-06-30
• First posted: 2022-08-08
• Last updated: 2025-09-05

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study