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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This single ascending dose (SAD) 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 compensated cirrhosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaIN
• Treatments: Terlipressin

Criteria

Inclusion Criteria:

1. Body mass index within the range 18 to 40 kg/m2 (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. Patients with liver cirrhosis confirmed by reliable biopsy (within 12 months) or reliable Fibroscan >15 kPa at screening.

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) <90 ml/min/1.73 m2 or Cr >1.2 mg/dL.

5. Hepatic encephalopathy ≥ grade 1.

6. Patients with Grade ≥ 3 or larger esophageal varices (per Conn's classification of esophageal varices) or red spots on most recent eligibility EGD.

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

8. Use of treatments for Hepatitis C virus within 6 months of Screening or anticipated use during the trial. Positive HCV antibody serology with detectable HCV ribonucleic acid (RNA).

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

10. Patients with acute hepatitis B; pPatients with known chronic hepatitis B are eligible if treatment regimen is not changed in the 4 weeks prior to study inclusion