Recruiting
Phase 1

PHIN-214

Sponsor:

PharmaIN

Code:

NCT05490888

Conditions

Cirrhosis, Liver

Liver Fibrosis

Ascites Hepatic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PHIN-214 Subcutaneous injection

Study Details

Brief 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.

Conditions

Cirrhosis, Liver

Liver Fibrosis

Ascites Hepatic

Study ID

NCT05490888

Start date

Jan 3, 2022

Status verified date

Sep, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

74 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: single dose of PHIN-214

Participants in Part 1 will receive one dose of PHIN-214 administered subcutaneously. Dose level will be assigned in ascending doses to observe initial safety and tolerability. A Safety Committee will review information from each patient and determine the dose level for the subsequent participants.

experimental: multiple daily dosing of PHIN-214

Participants in Part 2 will be trained to give themselves a daily dose of PHIN-214 at home by subcutaneous injection for 28-days. The dose level assigned to each participant will be determined by a Safety Committee after reviewing information from the last participants' experience and compilation of experiences on all previous participants. Dose level advancement will be guided throughout the study by the experiences and information collected from each participant.

Interventions

PHIN-214 Subcutaneous injection

subcutaneous injection(s) with PHIN-214 terlipressin derivative

Primary outcome measure

  • 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 ]
  • Pharmacokinetics of PHIN-214 [ Time Frame: up to six weeks ]
  • Pharmacokinetics of PHIN-214 metabolite [ Time Frame: up to six weeks ]

Central Contacts and Locations

Central contacts

Locations

Arizona Liver Health

Recruiting

Chandler, Arizona, United States, 85224

Contacts

Southern California Research Center

Recruiting

Coronado, California, United States, 92118

Contacts

Tandem Clinical Research

Recruiting

Marrero, Louisiana, United States, 70072

Contacts

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Methodist Health System, Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

Contacts

VA North Texas Healthcare System

Recruiting

Dallas, Texas, United States, 75216

Contacts

Principal Investigator:

Jacqueline O'Leary, MD

Texas Liver Institute

Recruiting

San Antonio, Texas, United States, 78215

Contacts

More Information

Sponsor

PharmaIN

Last update posted

Sep 5, 2025

Last verified

Sep, 2025

Keywords

  • Terlipressin
  • Cirrhosis
  • Vasoconstrictor
  • Refractory Ascites

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by PharmaIN on 2025-09-05.