Current partner codePEPTIDESDE
NCT05490888·Phase 1·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 1

Enrollment

74

Locations

9

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

PHIN-214 Subcutaneous injection

subcutaneous injection(s) with PHIN-214 terlipressin derivative

Timeline

From registration to results.

  1. First posted

    Aug 8, 2022

  2. Study start

    Jan 3, 2022

  3. Primary completion

    May 31, 2026

  4. Study completion

    Jun 30, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Sep 5, 2025

Outcomes

What the study measures.

Primary 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

Secondary outcomes

Immunogenicity of PHIN-214

Time frame · up to six weeks

anti-drug antibody testing

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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

9 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Terlipressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.