Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
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
PharmaIN
74 participants
Jan 3, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria8
- 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).
- 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).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
subcutaneous injection(s) with PHIN-214 terlipressin derivative
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05490888