Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03989440
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2019-06-11
Brief Title:
AXER-204 in Participants With Chronic Spinal Cord Injury
Sponsor:
ReNetX Bio Inc
Organization:
ReNetX Bio Inc
Study Overview
Official Title:
A Multicenter Two Part Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of AXER-204 in Subjects With Chronic Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2023-07
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:
RESET
Brief Summary:
This two-part trial will assess the safety tolerability pharmacokinetics and efficacy of AXER-204 administered by lumbar puncture and slow bolus infusion Part 1 will evaluate the safety tolerability and pharmacokinetics of single ascending doses of AXER-204 Part 2 will evaluate the safety tolerability pharmacokinetics and efficacy of repeated doses AXER-204 in comparison to placebo
Detailed Description:
AXER-204 is a human fusion protein that acts as a soluble decoytrap for the myelin-associated inhibitors of axonal growth known as Nogo-A MAG and OMgp AXER-204 and a surrogate protein used in early preclinical studies have been found to promote axon growth and recovery of function in animal models of spinal cord injury
Part 1 of the trial is a multicenter open-label single ascending dose study in participants with chronic cervical spinal cord injury Four cohorts of 6 participants each are planned with participants within each cohort expected to receive the same dose of AXER-204
Part 2 is a multicenter randomized double-blind placebo-controlled repeat dose study in chronic cervical spinal cord injury participants Approximately 32 participants will be randomized ratio 11 to receive repeated doses of AXER-204 or placebo a phosphate buffered saline formulation The dose level and dose frequency will be dependent upon outcomes from Part 1
Part 1 of the trial is a multicenter open-label single ascending dose study in participants with chronic cervical spinal cord injury Four cohorts of 6 participants each are planned with participants within each cohort expected to receive the same dose of AXER-204
Part 2 is a multicenter randomized double-blind placebo-controlled repeat dose study in chronic cervical spinal cord injury participants Approximately 32 participants will be randomized ratio 11 to receive repeated doses of AXER-204 or placebo a phosphate buffered saline formulation The dose level and dose frequency will be dependent upon outcomes from Part 1
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