PHIN-214 Subcutaneous injection: subcutaneous injection(s) with PHIN-214 terlipressin derivative
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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).
Primary outcome measure(s)
maximum tolerated dose or optimal beneficial dose of PHIN-214 in multiple ascending dose; safety and tolerability. — may be up to six weeks Incidence of adverse effects (type and severity), incidence of dose limiting toxicities, changes in key laboratory measures
Pharmacokinetics of PHIN-214 — up to six weeks plasma concentration of PHIN-214
Pharmacokinetics of PHIN-214 metabolite — up to six weeks plasma concentration of PHIN-214 metabolite
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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