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NCT05490888 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Cirrhosis, Liver and Liver Fibrosis, sponsored by PharmaIN.

Recruiting
Registry status
Phase 1
Development phase
74
Enrollment target
9
Study locations

NCT05490888 is a Phase 1 study of Cirrhosis, Liver and Liver Fibrosis that is actively recruiting participants, run by PharmaIN. The registered enrollment target is 74 participants, below the 240-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (69% lower). The trial reports 9 study locations across 7 states.

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The verdict

NCT05490888, a Phase 1 study of Cirrhosis, Liver and Liver Fibrosis, is actively recruiting participants, sponsored by PharmaIN.

RECRUITING
Registry status
Phase 1
Development phase
74 participants
Enrollment target
9
Study locations

Study 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.

Interventions

  • DRUG PHIN-214 Subcutaneous injection

Study Locations (9)

Texas

  • Methodist Health System, Dallas Medical Center - Dallas
  • VA North Texas Healthcare System - Dallas
  • Texas Liver Institute - San Antonio

Arizona

  • Arizona Liver Health - Chandler

California

  • Southern California Research Center - Coronado

Louisiana

  • Tandem Clinical Research - Marrero

Minnesota

  • Mayo Clinic - Rochester

Ohio

  • Cleveland Clinic - Cleveland

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2022-01-03
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

PharmaIN

1 total trials

What the Registry Record Tells You About NCT05490888

The ClinicalTrials.gov registry entry for NCT05490888 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 240-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (69% lower). The listed sponsor is PharmaIN, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Cirrhosis, Liver appearing as the primary indexed condition, and to 1 intervention - of which PHIN-214 Subcutaneous injection is the first listed.

NCT05490888 reports 9 study locations spanning 7 distinct geographic areas - top geographies include Texas, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT05490888 about?

NCT05490888 is a clinical study titled "Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics". 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 ma...

What is the current status of trial NCT05490888?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2022-01-03. Estimated completion is 2026-06-30.

What conditions does trial NCT05490888 study?

This clinical trial studies the following conditions: Cirrhosis, Liver, Liver Fibrosis, Ascites Hepatic.

What interventions are being tested in trial NCT05490888?

The interventions under investigation include: PHIN-214 Subcutaneous injection (DRUG).

Who is sponsoring clinical trial NCT05490888?

This trial is sponsored by PharmaIN, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05490888 being conducted?

This trial has 9 study locations across Arizona, California, Louisiana, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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