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RecruitingPhase 1

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

PharmaIN · NCT05490888

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
74
US sites recruiting
9
Study start
January 3, 2022
Record last updated
September 5, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: PHIN-214 Subcutaneous injection

Conditions: Cirrhosis, Liver; Liver Fibrosis; Ascites Hepatic

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • 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

  • 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).

Recruiting US locations

  • Arizona Liver Health

    Chandler, AZ 85224

    Site contact: Angie Coste, FNP-C · 480-470-4000 · acoste@azliver.com

  • Southern California Research Center

    Coronado, CA 92118

    Site contact: Kasey Seyer · 619-522-0330 · kasey@researchscrc.com

  • Tandem Clinical Research

    Marrero, LA 70072

    Site contact: Alexis Johnson · 504-934-8424 · AJohnson@tandemclinicalresearch.com

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Amy Olofson, RN · 507-538-6547 · Olofson.Amy@mayo.edu

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Keralee Morey · 216-215-0808 · moreyk@ccf.org

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Margaret Bussineau · 215-615-3755 · Margaret.Bussineau@Pennmedicine.upenn.edu

  • Methodist Health System, Dallas Medical Center

    Dallas, TX 75203

    Site contact: Crystee Cooper · 214-947-1280 · clinicalresearch@mhd.com

  • VA North Texas Healthcare System

    Dallas, TX 75216

    Site contact: Jacqueline O'Leary, MD · 214-857-0403 · Jacqueline.Oleary@va.gov

  • Texas Liver Institute

    San Antonio, TX 78215

    Site contact: Eric Lawitz, MD · 210-253-3426 · Lawitz@txliver.com

Study contacts (from the official record)

  • Cynthia C Jones · 206-568-1450 · PHIN.214001@pharmain.com
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Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A… (NCT05490888) | Bored Studies