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


About this study

The purpose of this study is to establish the Maximum Tolerated Dose (MTD), assess the safety, tolerability, and pharmacokinetics of subcutaneous PHIN-214 in participants with compensated and decompensated cirrhosis. In addition, various exploratory markers of effectiveness will be analyzed. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Body mass index within the range 18 to 40 kg/m^2 (inclusive) at screening.

2. Females must be non-pregnant, non-lactating or of non-childbearing potential or using highly efficient contraception for the full duration of the study.

3. Cirrhosis based on histology or a combination of clinical, radiological, or biochemical and classified as Child-Pugh A or B.

Exclusion Criteria:

1. Significant abnormalities in medical history or on physical examination, including:   respiratory disease requiring therapy or history of respiratory failure, cardiovascular disease or hypertension, electrocardiogram abnormalities or history of significant EKG abnormalities.

2. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.

3. Significant kidney disease.

4. Estimated glomerular filtration rate (eGFR by CKD-Epi) < 60 ml/min/1.73 m^2 or Cr > 2.0 mg/dL.

5. Hepatic encephalopathy > grade 2 in the previous 3 months. Stable drug treatment for HE is not exclusionary.

6. Recipient of a transjugular intrahepatic portosystemic shunt (TIPS).

7. Known positive HIV serology confirmed by HIV viral load.

8. Subjects with acute infections, including acute viral hepatitis are to be excluded.  Subjects with chronic hepatitis B are eligible if treatment regimen is stable ≥ 3
months prior to study inclusion.

Eligibility last updated 8/23/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Douglas Simonetto, M.D.

Open for enrollment

Contact information:

Amy Olofson R.N.

(507) 538-6547

More information


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