PHIN-214 for Liver Cirrhosis

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: PharmaIN

Disqualifiers: Respiratory disease, Cardiovascular disease, Diabetes, others

No Placebo Group

Trial Summary

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.

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.

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

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

+2 more

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.

+5 more

Trial 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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: single dose of PHIN-214Experimental Treatment1 Intervention

single ascending dose of PHIN-214

Group II: multiple daily dosing of PHIN-214Experimental Treatment1 Intervention

multiple doses of PHIN-214, daily for 28 days