PHIN-214 Subcutaneous injection for Ascites

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Arizona Liver Health, Chandler, AZ
Ascites+5 More
PHIN-214 Subcutaneous injection - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This single ascending dose (SAD) study evaluates PHIN-214, being studied to determine the safety, tolerability, and pharmacokinetics, and establish the maximum tolerated dose of this compound in patients with compensated cirrhosis.

Eligible Conditions

  • Ascites
  • Fibrosis, Liver
  • Cirrhosis of the Liver

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: up to two weeks

up to two weeks
AUC of PHIN-214
AUC of PHIN-214 metabolite
Incidence of dose limiting toxicities
PK of PHIN-214
PK of PHIN-214 metabolite
incidence of AEs
incidence of stopping criteria
various exploratory markers of efficacy

Trial Safety

Trial Design

1 Treatment Group

single dose of PHIN-214
1 of 1
Experimental Treatment

13 Total Participants · 1 Treatment Group

Primary Treatment: PHIN-214 Subcutaneous injection · No Placebo Group · Phase 1

single dose of PHIN-214
Drug
Experimental Group · 1 Intervention: PHIN-214 Subcutaneous injection · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to two weeks
Closest Location: Arizona Liver Health · Chandler, AZ
Photo of arizona 1Photo of arizona 2Photo of arizona 3
2020First Recorded Clinical Trial
1 TrialsResearching Ascites
10 CompletedClinical Trials

Who is running the clinical trial?

PharmaINLead Sponsor
Cynthia C Jones, BSStudy ChairPharmaIN

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.