PHIN-214 for Liver Cirrhosis

Recruiting at 9 trial locations

Overseen By Mangesh Pagadala, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: PharmaIN

Disqualifiers: Respiratory disease, Cardiovascular disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, PHIN-214, for individuals with liver cirrhosis. Researchers aim to determine the safety of PHIN-214 and its behavior in the body, focusing on those with mild to moderate liver damage (not severe). Participants will receive either a single dose or multiple doses daily for 28 days. Suitable candidates have liver cirrhosis confirmed by tests and do not have severe health issues like major heart or kidney disease. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have chronic hepatitis B, your treatment must be stable for at least 3 months before joining the study.

Is there any evidence suggesting that PHIN-214 is likely to be safe for humans?

Research has shown that PHIN-214 is being tested for safety in people with liver cirrhosis. These studies are in the early stages, focusing mainly on the treatment's safety and tolerability in humans. PHIN-214 is a drug that manages blood pressure by targeting specific pathways in the body.

In animal studies, such as those with rats, PHIN-214 has shown promise in reducing certain pressures in the liver, suggesting it might work similarly in humans. However, it's important to remember that results in animals do not always translate directly to humans.

This ongoing research aims to determine the safe dosage for patients. Since it's still early, more information is needed to fully understand the potential side effects and human tolerability. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about PHIN-214 for liver cirrhosis because it offers a novel approach compared to current treatments like lifestyle changes, medications to manage symptoms, and in severe cases, liver transplantation. Unlike these standard treatments, PHIN-214 is designed to directly target the underlying mechanisms of liver cirrhosis. It works by potentially regenerating liver tissue and reducing fibrosis, which is a buildup of scar tissue in the liver. This could mean not just managing symptoms but addressing the root cause, offering hope for improved liver function and quality of life for patients.

What evidence suggests that PHIN-214 might be an effective treatment for liver cirrhosis?

Previous studies have shown that PHIN-214 holds promise for treating liver conditions. It partially activates a specific receptor, which helps lower blood pressure in the liver. In animal studies, PHIN-214 reduced this pressure by about 13.4% within a few hours, potentially helping to manage symptoms related to liver cirrhosis. PHIN-214 also appears safer than similar treatments like terlipressin. These findings suggest that PHIN-214 might be effective for people with liver cirrhosis. Participants in this trial will receive either a single dose or multiple daily doses of PHIN-214 to evaluate its effectiveness and safety. ^{3 4 6 7 8}

Who Is on the Research Team?

Cynthia C Jones

Principal Investigator

PharmaIN

Are You a Good Fit for This Trial?

This trial is for adults with a BMI of 18-40 who have liver cirrhosis confirmed by biopsy or Fibroscan. They must not be pregnant, breastfeeding, and should use effective contraception. Excluded are those with significant heart, lung, kidney diseases, certain hepatitis conditions, hepatic encephalopathy grade 1 or higher, TIPS recipients, HIV positive individuals or those with fluid/sodium balance disorders.

Inclusion Criteria

You have been diagnosed with Liver Cirrhosis

You have been diagnosed with Liver Cirrhosis

I am not pregnant, breastfeeding, and either cannot have children or am using effective birth control.

Exclusion Criteria

I am HIV positive, confirmed by a viral load test.

I have chronic hepatitis B but haven't changed my treatment in the last 4 weeks.

I do not have major heart, lung, or blood pressure problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Dose Treatment

Participants receive a single ascending dose of PHIN-214 to evaluate safety and pharmacokinetics

1 day

1 visit (in-person)

Multiple Dose Treatment

Participants receive multiple daily doses of PHIN-214 for 28 days to establish the maximum tolerated dose

4 weeks

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PHIN-214

Trial Overview

The study tests PHIN-214 via subcutaneous injection to assess its safety and how the body processes it in patients with mild to moderate liver cirrhosis (Child-Pugh A and B). It aims to find the highest dose patients can tolerate without serious side effects through escalating doses.

How Is the Trial Designed?

Group I: single dose of PHIN-214 Experimental Treatment 1 Intervention

Participants in Part 1 will receive one dose of PHIN-214 administered subcutaneously. Dose level will be assigned in ascending doses to observe initial safety and tolerability. A Safety Committee will review information from each patient and determine the dose level for the subsequent participants.

Group II: multiple daily dosing of PHIN-214 Experimental Treatment 1 Intervention

Participants in Part 2 will be trained to give themselves a daily dose of PHIN-214 at home by subcutaneous injection for 28-days. The dose level assigned to each participant will be determined by a Safety Committee after reviewing information from the last participants' experience and compilation of experiences on all previous participants. Dose level advancement will be guided throughout the study by the experiences and information collected from each participant.

Who Is Running the Clinical Trial?

PharmaIN

Lead Sponsor

Trials

1

Recruited

50+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S0753332223018668

PHIN-214, a partial vasopressin receptor 1A agonist

PHIN-214 is a SC drug with 10-fold higher therapeutic index than terlipressin. •. PHIN-214 was effective in portal hypertensive bile duct ligated rat model. •.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05490888

Single and Multiple Dose Escalation of PHIN-214 in Child ...

This study will evaluate a single dose of PHIN-214 (in Part 1) and in Part 2, daily doses of PHIN-214 for up to 28-days (called multiple ascending doses) of ...

3.

pharmain.com

pharmain.com/2025/10/15/pharmain-corporation-to-present-phase-1-single-ascending-dose-results-from-phin-001-study-of-phin-214-in-patients-with-compensated-and-decompensated-cirrhosis-at-the-american-association-for-the-study/

BOTHELL, WA, October 15, 2025

PHIN-214 is a novel vasopressin analogue with partial V1a receptor agonism, reduced V2 activity, and a wide therapeutic index designed to induce ...

4.

mayo.edu

mayo.edu/research/clinical-trials/cls-20532643

Single and Multiple Dose Escalation of PHIN-214 in Child ...

The purpose of this study is to establish the Maximum Tolerated Dose (MTD), assess the safety, tolerability, and pharmacokinetics of subcutaneous PHIN-214.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38176129/

PHIN-214, a partial vasopressin receptor 1A agonist - PubMed

In bile duct ligated rats with PH, subcutaneous PHIN-214 reduced portal pressure by 13.4 % ± 3.4 in 4 h.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05490888

Single and Multiple Dose Escalation of PHIN-214 in Child- ...

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).

7.

pharmain.com

pharmain.com/2024/10/16/pharmain-to-present-promising-interim-data-from-its-ongoing-phase-1-trial-of-phin-214-an-optimized-vasopressor-for-decompensated-cirrhosis-at-the-liver-meeting-2024/

PharmaIN Corporation

PHIN-214 is an optimized vasopressor therapy targeting a clinically validated mechanism of action enabling safe, subcutaneous administration and ...

8.

withpower.com

withpower.com/trial/phase-1-liver-cirrhosis-2022-5796d

PHIN-214 for Liver Cirrhosis

This Phase 1 medical study run by PharmaIN is evaluating whether PHIN-214 will have tolerable side effects & efficacy for patients with Malignant Ascites, ...