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RECRUITING
NCT05490888
PHASE1

Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics

Sponsor: PharmaIN

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2022-01-03

Completion Date

2026-06-30

Last Updated

2025-09-05

Healthy Volunteers

No

Interventions

DRUG

PHIN-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