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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
PharmaIN
Study ID
NCT05490888
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Ascites Hepatic
  • Cirrhosis, Liver
  • Liver Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PHIN-214 Subcutaneous injection — DRUG
    subcutaneous injection(s) with PHIN-214 terlipressin derivative

Study Details

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.

Key Dates

Start date
Jan 3, 2022
Status verified
Sep 2025
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
74 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: single dose of PHIN-214
    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.
  • Experimental: multiple daily dosing of PHIN-214
    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.

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 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Arizona Liver HealthChandlerArizona85224
Angie Coste, FNP-C
[email protected]
480-470-4000
Southern California Research CenterCoronadoCalifornia92118
Kasey Seyer
[email protected]
619-522-0330
Tandem Clinical ResearchMarreroLouisiana70072
Alexis Johnson
[email protected]
504-934-8424
Mayo ClinicRochesterMinnesota55905
Amy Olofson, RN
[email protected]
507-538-6547
Cleveland ClinicClevelandOhio44195
Keralee Morey
[email protected]
216-215-0808
University of PennsylvaniaPhiladelphiaPennsylvania19104
Margaret Bussineau
[email protected]
215-615-3755
Methodist Health System, Dallas Medical CenterDallasTexas75203
Crystee Cooper
[email protected]
214-947-1280
VA North Texas Healthcare SystemDallasTexas75216
Jacqueline O'Leary, MD
[email protected]
214-857-0403
Jacqueline O'Leary, MD (PRINCIPAL_INVESTIGATOR)
Texas Liver InstituteSan AntonioTexas78215
Eric Lawitz, MD
[email protected]
210-253-3426

Find similar trials in Chandler, AZ

By research site
Arizona Liver Health· Chandler, AZSouthern California Research Center· Coronado, CATandem Clinical Research· Marrero, LAMayo Clinic· Rochester, MNCleveland Clinic· Cleveland, OHUniversity of Pennsylvania· Philadelphia, PA

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