PHIN-214 for Liver Cirrhosis

Recruiting at 7 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

48 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

This single and multiple ascending dose (SAD and MAD) study evaluates PHIN-214, being studied to determine the safety, tolerability, and pharmacokinetics, and establish the maximum tolerated dose of this compound in patients with Child Pugh A and B Cirrhosis.

Research Team

Cynthia C Jones

Principal Investigator

PharmaIN

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

single ascending dose of PHIN-214

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

multiple doses of PHIN-214, daily for 28 days

Who Is Running the Clinical Trial?

PharmaIN

Lead Sponsor

Trials

1

Recruited

50+