Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
Key facts
- Who runs it
- PharmaIN
- Where
- Chandler, Cleveland, Coronado, Dallas, Marrero, Philadelphia, Rochester, and San Antonio, United StatesSee the 9 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 74 people, planned
- Started
- 3 Jan 2022
- Planned end
- 30 Jun 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- PHIN-214 Subcutaneous injection
- Record updated
- 5 September 2025
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- History of cirrhosis based on histology or a combination of clinical, radiological, or biochemical assessment and classified as Child-Pugh A or B
- Participants may be male or female aged 18 to 75 years
- Body mass index (BMI) within the range 18 to 40 kg/m2 (inclusive) at screening
- 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
Who cannot take part
- 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
- 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)
- 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
- Significant kidney disease
- Acute-on-chronic liver failure
- Known positive HIV serology confirmed by HIV viral load
- History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance
- Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in United States
- Arizona Liver HealthChandler, United StatesContact: Angie Coste, FNP-CTaking people
- Cleveland ClinicCleveland, United StatesContact: Keralee MoreyTaking people
- Southern California Research CenterCoronado, United StatesContact: Kasey SeyerTaking people
- Methodist Health System, Dallas Medical CenterDallas, United StatesContact: Crystee CooperTaking people
- VA North Texas Healthcare SystemDallas, United StatesContact: Jacqueline O'Leary, MDTaking people
- Tandem Clinical ResearchMarrero, United StatesContact: Alexis JohnsonTaking people
- University of PennsylvaniaPhiladelphia, United StatesContact: Margaret BussineauTaking people
- Mayo ClinicRochester, United StatesContact: Amy Olofson, RNTaking people
- Texas Liver InstituteSan Antonio, United StatesContact: Eric Lawitz, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- single dose of PHIN-214Treatment being tested
Participants in Part 1 will receive one dose of PHIN-214 administered subcutaneously. Dose level will be assigned in ascending doses to observe initial safety and tolerability. A Safety Committee will review information from each patient and determine the dose level for the subsequent participants.
Treatment: PHIN-214 Subcutaneous injection
- multiple daily dosing of PHIN-214Treatment being tested
Participants in Part 2 will be trained to give themselves a daily dose of PHIN-214 at home by subcutaneous injection for 28-days. The dose level assigned to each participant will be determined by a Safety Committee after reviewing information from the last participants' experience and compilation of experiences on all previous participants. Dose level advancement will be guided throughout the study by the experiences and information collected from each participant.
Treatment: PHIN-214 Subcutaneous injection
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 1 Open Label Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PHIN-214 in Adults With Child Pugh A and B Cirrhosis
- Fit questions
- Built from NCT05490888, who can take part
- Record updated
- 5 September 2025