RecruitingPhase 1NCT05490888

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


Sponsor

PharmaIN

Enrollment

74 participants

Start Date

Jan 3, 2022

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PHIN-214 Subcutaneous injection for people with ascites hepatic, cirrhosis, liver, and other related conditions. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPHIN-214 Subcutaneous injection

subcutaneous injection(s) with PHIN-214 terlipressin derivative


Locations(9)

Arizona Liver Health

Chandler, Arizona, United States

Southern California Research Center

Coronado, California, United States

Tandem Clinical Research

Marrero, Louisiana, United States

Mayo Clinic

Rochester, Minnesota, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Methodist Health System, Dallas Medical Center

Dallas, Texas, United States

VA North Texas Healthcare System

Dallas, Texas, United States

Texas Liver Institute

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05490888


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