Cirrhosis, LiverPhase 1NCT05490888
Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics
A Phase 1 study testing PHIN-214 Subcutaneous injection in people with Cirrhosis, Liver and Liver Fibrosis, run by PharmaIN at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Liver, Liver Fibrosis, Ascites Hepatic
- What is being tested?
- PHIN-214 Subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 9 sitesUnited States
- Study dates
- 3 Jan 2022to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
- 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).
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Arizona Liver Health
Chandler, Arizona, 85224
Angie Coste, FNP-C, 480-470-4000, acoste@azliver.com
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Keralee Morey, 216-215-0808, moreyk@ccf.org
- Recruiting
Southern California Research Center
Coronado, California, 92118
Kasey Seyer, 619-522-0330, kasey@researchscrc.com
- Recruiting
Methodist Health System, Dallas Medical Center
Dallas, Texas, 75203
Crystee Cooper, 214-947-1280, clinicalresearch@mhd.com
- Recruiting
VA North Texas Healthcare System
Dallas, Texas, 75216
Jacqueline O'Leary, MD, 214-857-0403, Jacqueline.Oleary@va.gov
Jacqueline O'Leary, MD
- Recruiting
Tandem Clinical Research
Marrero, Louisiana, 70072
Alexis Johnson, 504-934-8424, AJohnson@tandemclinicalresearch.com
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Margaret Bussineau, 215-615-3755, Margaret.Bussineau@Pennmedicine.upenn.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Amy Olofson, RN, 507-538-6547, Olofson.Amy@mayo.edu
- Recruiting
Texas Liver Institute
San Antonio, Texas, 78215
Eric Lawitz, MD, 210-253-3426, Lawitz@txliver.com
About this study
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
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.
Read the detailed description
PHIN-214 action has similar actions as another medication called "terlipressin or TERLIVAZ®." Terlipressin has been shown to reduce portal hypertension, improve renal function, and induce natriuresis in cirrhotic patients with ascites without hepatorenal syndrome (HRS). It is approved in several countries including the US for the treatment of bleeding esophageal varices and HRS type 1 and is usually administered using multiple IV doses given by bolus injections in the hospital.
This study is an open label, first in human study of PHIN-214. PHIN-214 is a terlipressin derivative administered subcutaneously. It is a partial V1a agonist which is designed to reduce splanchnic blood pooling and portal hypertension. A resultant increase in systemic pressure and renal arterial pressure may increase kidney perfusion and creatinine clearance.
This study will evaluate a single dose of PHIN-214 (in Part 1) and in Part 2, daily doses of PHIN-214 for up to 28-days (called multiple ascending doses) of PHIN-214 to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of PHIN-214 in subjects with advanced cirrhosis.
- Conditions
- Cirrhosis, Liver, Liver Fibrosis, Ascites Hepatic
- Being tested
- PHIN-214 Subcutaneous injection
- Keywords
- Terlipressin, Cirrhosis, Vasoconstrictor, Refractory Ascites
- Medical subject headings
- Liver Cirrhosis, Fibrosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHIN-214 Subcutaneous injectionDrug
Also called Terlipressin derivative
subcutaneous injection(s) with PHIN-214 terlipressin derivative
| Study group | Role | What they receive |
|---|---|---|
| single dose of PHIN-214 | Experimental | 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. Receives: Drug: PHIN-214 Subcutaneous injection |
| multiple daily dosing of PHIN-214 | Experimental | 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. Receives: Drug: PHIN-214 Subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: may be up to six weeks
Pharmacokinetics of PHIN-214
plasma concentration of PHIN-214
Measured: up to six weeks
Pharmacokinetics of PHIN-214 metabolite
plasma concentration of PHIN-214 metabolite
Measured: up to six weeks
Secondary outcomes (1)
Immunogenicity of PHIN-214
anti-drug antibody testing
Measured: up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start3 Jan 2022
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaIN
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cynthia C Jones, Study chair, PharmaIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490888
- Sponsor's protocol ID
- PHIN-001
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2022
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05490888
- Acronym / sponsor ID
- PHIN-001
- Conditions
- Cirrhosis, Liver, Liver Fibrosis, Ascites Hepatic
- Keywords
- Terlipressin, Cirrhosis, Vasoconstrictor, Refractory Ascites
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- PharmaINIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PHIN-214 action has similar actions as another medication called "terlipressin or TERLIVAZ®." Terlipressin has been shown to reduce portal hypertension, improve renal function, and induce natriuresis in cirrhotic patients with ascites without hepatorenal syndrome (HRS). It is approved in several countries including the US for the treatment of bleeding esophageal varices and HRS type 1 and is usually administered using multiple IV doses given by bolus injections in the hospital.
This study is an open label, first in human study of PHIN-214. PHIN-214 is a terlipressin derivative administered subcutaneously. It is a partial V1a agonist which is designed to reduce splanchnic blood pooling and portal hypertension. A resultant increase in systemic pressure and renal arterial pressure may increase kidney perfusion and creatinine clearance.
This study will evaluate a single dose of PHIN-214 (in Part 1) and in Part 2, daily doses of PHIN-214 for up to 28-days (called multiple ascending doses) of PHIN-214 to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of PHIN-214 in subjects with advanced cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single dose of PHIN-214 | Experimental | Drug: PHIN-214 Subcutaneous injectionParticipants 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 | Experimental | Drug: PHIN-214 Subcutaneous injectionParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHIN-214 Subcutaneous injectionAlso: Terlipressin derivativesubcutaneous injection(s) with PHIN-214 terlipressin derivative | Drug | multiple daily dosing of PHIN-214, single dose of PHIN-214 |
Primary outcome
maximum tolerated dose or optimal beneficial dose of PHIN-214 in multiple ascending dose; safety and tolerability.
Time frame: may be up to six weeks
Incidence of adverse effects (type and severity), incidence of dose limiting toxicities, changes in key laboratory measures
Pharmacokinetics of PHIN-214
Time frame: up to six weeks
plasma concentration of PHIN-214
Pharmacokinetics of PHIN-214 metabolite
Time frame: up to six weeks
plasma concentration of PHIN-214 metabolite
1 secondary outcome
Immunogenicity of PHIN-214
Time frame: up to six weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cynthia C Jones study chair
PharmaIN
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PHIN-214 Subcutaneous injection in people with Cirrhosis, Liver and Liver Fibrosis, run by PharmaIN at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia C Jones (206-568-1450, PHIN.214001@pharmain.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum tolerated dose or optimal beneficial dose of PHIN-214 in multiple ascending dose; safety and tolerability. (time frame: may be up to six weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.