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

RecruitingPhase 1Ages 18 Years - 75 YearsAllPharmaIN
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 3 months prior to study inclusion).
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What it tests

  • PHIN-214 Subcutaneous injection
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Where

9 sites
Arizona Liver Health
Chandler, United States
Southern California Research Center
Coronado, United States
Tandem Clinical Research
Marrero, United States
Mayo Clinic
Rochester, United States
Cleveland Clinic
Cleveland, United States
University of Pennsylvania
Philadelphia, United States
Methodist Health System, Dallas Medical Center
Dallas, United States
VA North Texas Healthcare System
Dallas, United States

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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