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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cirrhosis, Liver
Intervention / Treatment

-

Contacts and Locations

Chandler

Arizona Liver Health, Chandler, Arizona, United States, 85224

Coronado

Southern California Research Center, Coronado, California, United States, 92118

Marrero

Tandem Clinical Research, Marrero, Louisiana, United States, 70072

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Dallas

Methodist Health System, Dallas Medical Center, Dallas, Texas, United States, 75203

San Antonio

Texas Liver Institute, San Antonio, Texas, United States, 78215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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).

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

PharmaIN,

Cynthia C Jones, STUDY_CHAIR, PharmaIN

Study Record Dates

2026-06-30