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Clinical Trial Details

Trial ID: L1660
Source ID: NCT06283589
Associated Drug: Inz-701
Title: The SEAPORT 1 Study: Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stage Kidney Disease Undergoing Hemodialysis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Calciphylaxis
Interventions: DRUG: INZ-701
Outcome Measures: Primary: Determine if INZ-701 increases PPi levels, For each participant, plasma PPi will be measured via a series of blood samples obtained throughout the study, comparing the participant's baseline value over time to determine if there's been a change., 26 days (Treatment Period) | Secondary: Assess the Time to Maximum Serum Concentration (Tmax), For each participant, the maximum concentration of INZ-701 in the serum will be measured via a series of blood samples obtained throughout the study, comparing the participant's baseline value over time., 26 days (Treatment Period)|Assess the Maximum Serum Concentration (Cmax) of INZ-701, For each participant, the maximum concentration of INZ-701 in the serum will be measured via a series of blood samples obtained throughout the study, comparing the participant's baseline value over time., 26 days (Treatment Period)|Assess the Area under the concentration-time curve over the dosing interval (AUCtau), For each participant, variation of concentration of INZ-701 in the serum will be measured via a series of blood samples obtained throughout the study, comparing the participant's baseline value over time., 26 days (Treatment Period)|Assess the Clearance after extravascular administration of drug (CL/F), For each participant, clearance of INZ-701 from the body will be measured via a series of blood samples obtained throughout the study, comparing the participant's baseline value over time., 26 days (Treatment Period)|Assess ENPP1 Activity, For each participant, ENPP1 activity is a measurement of INZ-701 activity in human serum using a chromogenic based method., 26 days (Treatment Period)
Sponsor/Collaborators: Sponsor: Inozyme Pharma
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 11
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-12
Completion Date: 2024-12-13
Results First Posted:
Last Update Posted: 2025-02-05
Locations: South Florida Nephrology Research, Coral Springs, Florida, 33071, United States|Elixia Health, Hollywood, Florida, 33024, United States
URL: https://clinicaltrials.gov/show/NCT06283589