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.
Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
At a glance
Conditions
Where it's being run
9 sites across 7 statesStudy leadership
- Cynthia C Jones · STUDY_CHAIR · PharmaIN
Who to contact
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What this trial measures
- 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