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

Last updated: September 3, 2025
Sponsor: PharmaIN
Overall Status: Active - Recruiting

Phase

1

Condition

Hyponatremia

Scar Tissue

Hepatic Fibrosis

Treatment

PHIN-214 Subcutaneous injection

Clinical Study ID

NCT05490888
PHIN-001
  • Ages 18-75
  • All Genders

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.

Eligibility Criteria

Inclusion

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-childbearingpotential or using highly efficient contraception for the full duration of the study

Exclusion

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 historyof significant EKG abnormalities.

  2. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormonesecretion, 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 syndromewith 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 withchronic hepatitis B are eligible if treatment regimen is stable ≥ 3 months prior tostudy inclusion).

Study Design

Total Participants: 74
Treatment Group(s): 1
Primary Treatment: PHIN-214 Subcutaneous injection
Phase: 1
Study Start date:
January 03, 2022
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Arizona Liver Health

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Arizona Liver Health

    Chandler 5289282, Arizona 5551752 85224
    United States

    Active - Recruiting

  • Southern California Research Center

    Coronado, California 92118
    United States

    Site Not Available

  • Southern California Research Center

    Coronado 5339663, California 5332921 92118
    United States

    Active - Recruiting

  • Tandem Clinical Research

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Tandem Clinical Research

    Marrero 4332628, Louisiana 4331987 70072
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Methodist Health System, Dallas Medical Center

    Dallas, Texas 75203
    United States

    Site Not Available

  • Texas Liver Institute

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Methodist Health System, Dallas Medical Center

    Dallas 4684888, Texas 4736286 75203
    United States

    Active - Recruiting

  • VA North Texas Healthcare System

    Dallas 4684888, Texas 4736286 75216
    United States

    Active - Recruiting

  • Texas Liver Institute

    San Antonio 4726206, Texas 4736286 78215
    United States

    Active - Recruiting

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