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SEAPORT 1: Study of INZ-701 in Adults With Hemodialysis-Dependent End-Stage Kidney Disease
Sponsor: Inozyme Pharma
Summary
This Phase 1, open-label, multicenter study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INZ-701 in adults with hemodialysis-dependent end-stage kidney disease (ESKD) and low plasma inorganic pyrophosphate (PPi) levels. Participants received INZ-701 1.8 mg/kg subcutaneously once weekly for 4 weeks. The study assessed changes in plasma PPi levels, PK characteristics, ENPP1-Fc activity, safety, tolerability, and immunogenicity.
Official title: The SEAPORT 1 Study: An Open-label Exploratory Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of INZ-701 in Study Participants With End-Stage Kidney Disease Undergoing Hemodialysis
Key Details
Gender
All
Age Range
18 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
11
Start Date
2024-02-12
Completion Date
2024-12-13
Last Updated
2026-08-24
Healthy Volunteers
No
Conditions
Interventions
INZ-701
Recombinant fusion protein that contains the extracellular domains of human ENPP1 coupled with an Fc fragment from an immunoglobulin gamma-1 (IgG1) antibody.
Locations (2)
South Florida Nephrology Research
Coral Springs, Florida, United States
Elixia Health
Hollywood, Florida, United States