PHIN-214 for Child-Pugh A and B Liver Cirrhosis

This study is testing a new medication called PHIN-214, which is given as a shot under the skin. It's for people with liver cirrhosis (scarring of the liver) classified as Child-Pugh A or B. The main goals are to find out how safe PHIN-214 is, how well people tolerate it, and how the body processes it. Researchers also want to find the best dose, either the highest dose that can be given safely or the dose that works best. PHIN-214 works similarly to another medication called terlipressin, which helps reduce pressure in the liver. This study is currently recruiting participants aged 18 to 75 with a BMI between 18 and 40.

Study design
This is an open-label study, meaning both you and the study team will know which treatment you are receiving. It will involve about 74 participants and will test PHIN-214 first as a single dose, then as daily doses for 28 days.
What's involved
Participants will receive PHIN-214 as a single dose in Part 1, or daily doses for up to 28 days in Part 2. The study will measure safety, tolerability, and how your body handles the drug for up to six weeks.
Compensation
Not stated in the trial record.
Follow-up
Your safety and how your body processes PHIN-214 will be monitored for up to six weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05490888

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

Recruiting
PHASE1Ages 18–75InterventionalTreatment
PharmaIN
~74 participants
Updated 2025-09-05 on ClinicalTrials.gov
What's tested:PHIN-214 Subcutaneous injection

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
maximum tolerated dose or optimal beneficial dose of PHIN-214 in multiple ascending dose; safety and tolerability.
Measured over may be up to six weeks
+2 more outcomes measured
Cirrhosis, Liver
Liver Fibrosis
Ascites Hepatic
9 sites across 7 states
Texas3
Arizona1
California1
Louisiana1
Minnesota1
Ohio1
Pennsylvania1
  • Cynthia C Jones · STUDY_CHAIR · PharmaIN

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  • maximum tolerated dose or optimal beneficial dose of PHIN-214 in multiple ascending dose; safety and tolerability.may be up to six weeks

    Incidence of adverse effects (type and severity), incidence of dose limiting toxicities, changes in key laboratory measures

  • Pharmacokinetics of PHIN-214up to six weeks

    plasma concentration of PHIN-214

  • Pharmacokinetics of PHIN-214 metaboliteup to six weeks

    plasma concentration of PHIN-214 metabolite