Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283589
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-02-21
Brief Title:
The SEAPORT 1 Study Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stage Kidney Disease Undergoing Hemodialysis
Sponsor:
Inozyme Pharma
Organization:
Inozyme Pharma
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if multiple doses of INZ-701 given once per week over 4 weeks are safe and increase pyrophosphate PPi levels in hemodialysis-dependent HD end stage kidney disease ESKD study participants who have low PPi levels In addition the effect of hemodialysis on the pharmacokinetics of INZ-701 and PPi levels will be evaluated
Detailed Description:
INZ-701 is an ectonucleotide pyrophosphatasephosphodiesterase 1 ENPP1 recombinant fusion protein in development for the treatment of calciphylaxis The SEAPORT 1 INZ701-401 Study is a Phase 1 open-label study to evaluate the safety pharmacokinetics PK and pharmacodynamics PD of multiple doses of INZ-701 in study participants aged 18 to 70 years with HD-dependent ESKD Anticipated enrollment in the study is up to 10 study participants The purpose of this study is to determine if INZ-701 increases PPi levels as well as assess the PK PD characteristics of INZ-701 in patients with clinically low PPi levels
The study will consist of a Screening Period lasting up to 30 days a Treatment and Assessment Period lasting 26 days an end of study EOS Visit 30 days after the last dose of INZ-701 and if necessary a safety visit 60 days after the last dose of INZ-701
The study will consist of a Screening Period lasting up to 30 days a Treatment and Assessment Period lasting 26 days an end of study EOS Visit 30 days after the last dose of INZ-701 and if necessary a safety visit 60 days after the last dose of INZ-701
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None