DRUG
PHIN-214 Subcutaneous injection
subcutaneous injection(s) with PHIN-214 terlipressin derivative
Status
Recruiting
Phase
Phase 1
Enrollment
74
Locations
9
Results
Not posted
Publications
0
Study 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.
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.
Interventions
DRUG
subcutaneous injection(s) with PHIN-214 terlipressin derivative
Timeline
First posted
Aug 8, 2022
Study start
Jan 3, 2022
Primary completion
May 31, 2026
Study completion
Jun 30, 2026
Results posted
Not reported
Registry updated
Sep 5, 2025
Outcomes
maximum tolerated dose or optimal beneficial dose of PHIN-214 in multiple ascending dose; safety and tolerability.
Time frame · may be up to six weeks
Incidence of adverse effects (type and severity), incidence of dose limiting toxicities, changes in key laboratory measures
Pharmacokinetics of PHIN-214
Time frame · up to six weeks
plasma concentration of PHIN-214
Pharmacokinetics of PHIN-214 metabolite
Time frame · up to six weeks
plasma concentration of PHIN-214 metabolite
Immunogenicity of PHIN-214
Time frame · up to six weeks
anti-drug antibody testing
Eligibility
Key Inclusion Criteria: 1. History of cirrhosis based on histology or a combination of clinical, radiological, or biochemical assessment and classified as Child-Pugh A or B 2. Participants may be male or female aged 18 to 75 years. 3. Body mass index (BMI) within the range 18 to 40 kg/m2 (inclusive) at screening. 4. Female participants must be non-pregnant, non-lactating, or of non-childbearing potential or using highly efficient contraception for the full duration of the study Key Exclusion Criteria: 1. Significant abnormalities in medical history or on physical examination, including: respiratory disease requiring therapy or history of respiratory failure, cardiovascular disease or hypertension, electrocardiogram abnormalities or history of significant EKG abnormalities. 2. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance. 3. Significant kidney disease 4. Hepatic encephalopathy (HE) or altered mental status requiring hospitalization; variceal bleeding or upper gastrointestinal bleeding; or type 1 hepatorenal syndrome with acute kidney injury (HRS-AKI) during the previous 3 months prior to Screening. 5. Acute-on-chronic liver failure. 6. Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS). 7. Known positive HIV serology confirmed by HIV viral load. 8. Subjects with acute infections, including acute viral hepatitis (subjects with chronic hepatitis B are eligible if treatment regimen is stable ≥ 3 months prior to study inclusion).
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Arizona Liver Health
Chandler, Arizona, United States
Southern California Research Center
Coronado, California, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Methodist Health System, Dallas Medical Center
Dallas, Texas, United States
VA North Texas Healthcare System
Dallas, Texas, United States
Texas Liver Institute
San Antonio, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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