Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics (NCT05490888) | Clinical Trial Compass
RecruitingPhase 1
Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
United States74 participantsStarted 2022-01-03
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. History of cirrhosis based on histology or a combination of clinical, radiological, or biochemical assessment and classified as Child-Pugh A or B
✓. Participants may be male or female aged 18 to 75 years.
✓. Body mass index (BMI) within the range 18 to 40 kg/m2 (inclusive) at screening.
✓. 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
Exclusion criteria
✕. 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.
✕. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.
✕. Significant kidney disease
✕. 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.
✕. Acute-on-chronic liver failure.
✕. Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS).
✕
What they're measuring
1
maximum tolerated dose or optimal beneficial dose of PHIN-214 in multiple ascending dose; safety and tolerability.
. Known positive HIV serology confirmed by HIV viral load.
✕. 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).