Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
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
1 other identifier
interventional
74
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2022
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2022
CompletedFirst Submitted
Initial submission to the registry
July 28, 2022
CompletedFirst Posted
Study publicly available on registry
August 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
September 5, 2025
September 1, 2025
4.4 years
July 28, 2022
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
maximum tolerated dose or optimal beneficial dose of PHIN-214 in multiple ascending dose; safety and tolerability.
Incidence of adverse effects (type and severity), incidence of dose limiting toxicities, changes in key laboratory measures
may be up to six weeks
Pharmacokinetics of PHIN-214
plasma concentration of PHIN-214
up to six weeks
Pharmacokinetics of PHIN-214 metabolite
plasma concentration of PHIN-214 metabolite
up to six weeks
Secondary Outcomes (1)
Immunogenicity of PHIN-214
up to six weeks
Other Outcomes (4)
Blood pressure
up to six weeks
Heart rate
up to six weeks
12-lead ECG
up to six weeks
- +1 more other outcomes
Study Arms (2)
single dose of PHIN-214
EXPERIMENTALParticipants 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.
multiple daily dosing of PHIN-214
EXPERIMENTALParticipants 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.
Interventions
subcutaneous injection(s) with PHIN-214 terlipressin derivative
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.
- Significant kidney disease
- 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.
- Acute-on-chronic liver failure.
- Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS).
- Known positive HIV serology confirmed by HIV viral load.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PharmaINlead
Study Sites (9)
Arizona Liver Health
Chandler, Arizona, 85224, United States
Southern California Research Center
Coronado, California, 92118, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Methodist Health System, Dallas Medical Center
Dallas, Texas, 75203, United States
VA North Texas Healthcare System
Dallas, Texas, 75216, United States
Texas Liver Institute
San Antonio, Texas, 78215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cynthia C Jones
PharmaIN
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2022
First Posted
August 8, 2022
Study Start
January 3, 2022
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
September 5, 2025
Record last verified: 2025-09