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

RecruitingPhase 1

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

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
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).

About the study

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.

What is being tested

Sponsor: PharmaIN · Participants: 74 · Started: Jan 3, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05490888

Locations in the U.S.

ArizonaArizona Liver Health, Chandler
CaliforniaSouthern California Research Center, Coronado
LouisianaTandem Clinical Research, Marrero
MinnesotaMayo Clinic, Rochester
OhioCleveland Clinic, Cleveland
PennsylvaniaUniversity of Pennsylvania, Philadelphia
TexasMethodist Health System, Dallas Medical Center, Dallas
VA North Texas Healthcare System, Dallas
Texas Liver Institute, San Antonio

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.