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
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.
Description
PHIN-214 action has similar actions as another medication called "terlipressin or TERLIVAZ®." Terlipressin has been shown to reduce portal hypertension, improve renal function, and induce natriuresis in cirrhotic patients with ascites without hepatorenal syndrome (HRS). It is approved in several countries including the US for the treatment of bleeding esophageal varices and HRS type 1 and is usually administered using multiple IV doses given by bolus injections in the hospital. This study is an open label, first in human study of PHIN-214. PHIN-214 is a terlipressin derivative administered su…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- 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: res…
Interventions
- DrugPHIN-214 Subcutaneous injection
subcutaneous injection(s) with PHIN-214 terlipressin derivative
Locations (9)
- Arizona Liver HealthChandler, Arizona
- Southern California Research CenterCoronado, California
- Tandem Clinical ResearchMarrero, Louisiana
- Mayo ClinicRochester, Minnesota
- Cleveland ClinicCleveland, Ohio
- University of PennsylvaniaPhiladelphia, Pennsylvania