Ignite Creation Date:
2024-05-06 @ 7:58 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02648269
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2016-01-05
Brief Title:
Safety and Pharmacodynamics of SEL-212 Pegsiticase SEL-110 in Subjects With Elevated Blood Uric Acid Levels
Sponsor:
Selecta Biosciences Inc
Organization:
Selecta Biosciences Inc
Study Overview
Official Title:
A Phase I Single Ascending Dose Safety Pharmacokinetic and Pharmacodynamics Study of SEL-212 in Subjects With Elevated Blood Uric Acid
Status:
COMPLETED
Status Verified Date:
2017-01
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:
This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110 a nanoparticle containing rapamycin in subjects with elevated blood uric acid levels This will be followed in separate subjects by evaluation of the safety pharmacokinetics pharmacodynamics and immunogenicity of a single intravenous dose of SEL-212 SEL-037 pegsiticase plus SEL-110 in subjects with elevated blood uric acid levels Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies ADAs from forming
Detailed Description:
This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110 a nanoparticle containing rapamycin in subjects with elevated blood uric acid levels This will be followed in separate subjects by evaluation of the safety pharmacokinetics pharmacodynamics and immunogenicity of a single intravenous dose of SEL-212 SEL-037 pegsiticase plus SEL-110 in subjects with elevated blood uric acid levels Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies ADAs from forming Cohorts of subjects in the SEL-110 only arms of the study will be given a single ascending intravenous dose of SEL-110 and then monitored for safety and rapamycin levels pharmacokinetics over 30 days Cohorts of subjects in the SEL-212 arms of the study will be given a single ascending intravenous dose of SEL-110 with a fixed dose of SEL-037 and then monitored for safety rapamycin levels SEL-037 levels uric acid levels and anti-drug-antibodies ADAs to SEL-037 for 30 days One additional control group with receive a single intravenous infusion of SEL-037 at a fixed dose and then monitored for safety SEL-037 levels uric acid levels and anti-drug-antibodies ADAs to SEL-037 for 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None