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
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Arizona Liver Health
RECRUITING
Chandler
California
Southern California Research Center
RECRUITING
Coronado
Louisiana
Tandem Clinical Research
RECRUITING
Marrero
Minnesota
Mayo Clinic
RECRUITING
Rochester
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Texas
Methodist Health System, Dallas Medical Center
RECRUITING
Dallas
VA North Texas Healthcare System
RECRUITING
Dallas
Texas Liver Institute
RECRUITING
San Antonio
Contact Information
Primary
Cynthia C Jones
PHIN.214001@pharmain.com
206-568-1450
Time Frame
Start Date:2022-01-03
Estimated Completion Date:2026-06-30
Participants
Target number of participants:74
Treatments
Experimental: single dose of PHIN-214
Participants in Part 1 will receive one dose of PHIN-214 administered subcutaneously. Dose level will be assigned in ascending doses to observe initial safety and tolerability. A Safety Committee will review information from each patient and determine the dose level for the subsequent participants.
Experimental: multiple daily dosing of PHIN-214
Participants in Part 2 will be trained to give themselves a daily dose of PHIN-214 at home by subcutaneous injection for 28-days. The dose level assigned to each participant will be determined by a Safety Committee after reviewing information from the last participants' experience and compilation of experiences on all previous participants. Dose level advancement will be guided throughout the study by the experiences and information collected from each participant.