NCT05490888 Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
| NCT ID | NCT05490888 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | PharmaIN |
| Condition | Cirrhosis, Liver |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2022-01-03 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 74 participants in total. It began in 2022-01-03 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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). Specifically, this study evaluates PHIN-214, to determine the safety, tolerability, and pharmacokinetic effects of PHIN-214, and to establish the maximum tolerated dose or optimal beneficial dose in patients with Child Pugh A and B Cirrhosis.
Eligibility Criteria
Key Inclusion Criteria: 1. History of cirrhosis based on histology or a combination of clinical, radiological, or biochemical assessment and classified as Child-Pugh A or B 2. Participants may be male or female aged 18 to 75 years. 3. Body mass index (BMI) within the range 18 to 40 kg/m2 (inclusive) at screening. 4. Female participants must be non-pregnant, non-lactating, or of non-childbearing potential or using highly efficient contraception for the full duration of the study Key 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. Hepatic encephalopathy (HE) or altered mental status requiring hospitalization; variceal bleeding or upper gastrointestinal bleeding; or type 1 hepatorenal syndrome with acute kidney injury (HRS-AKI) during the previous 3 months prior to Screening. 5. Acute-on-chronic liver failure. 6. Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS). 7. Known positive HIV serology confirmed by HIV viral load. 8. Subjects with acute infections, including acute viral hepatitis (subjects with chronic hepatitis B are eligible if treatment regimen is stable ≥ 3 months prior to study inclusion).
Contact & Investigator
Cynthia C Jones
STUDY CHAIR
PharmaIN
Frequently Asked Questions
Who can join the NCT05490888 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Cirrhosis, Liver. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05490888 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05490888 currently recruiting?
Yes, NCT05490888 is actively recruiting participants. Contact the research team at PHIN.214001@pharmain.com for enrollment information.
Where is the NCT05490888 trial being conducted?
This trial is being conducted at Chandler, United States, Coronado, United States, Marrero, United States, Rochester, United States and 5 additional locations.
Who is sponsoring the NCT05490888 clinical trial?
NCT05490888 is sponsored by PharmaIN. The principal investigator is Cynthia C Jones at PharmaIN. The trial plans to enroll 74 participants.