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

NCT05490888 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-09-05

No results posted yet for this 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.

Conditions

  • Cirrhosis, Liver
  • Liver Fibrosis
  • Ascites Hepatic

Interventions

DRUG

PHIN-214 Subcutaneous injection

subcutaneous injection(s) with PHIN-214 terlipressin derivative

Sponsors & Collaborators

  • PharmaIN

    lead INDUSTRY

Principal Investigators

  • Cynthia C Jones · PharmaIN

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-03
Primary Completion
2026-05-31
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05490888 on ClinicalTrials.gov