Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506305
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-21
Brief Title:
Clinical Study of FB1001 in Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A SingleMultiple Dose Escalation Open-Labeled Phase I Clinical Study to Assess the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of FB1001 in Patients With Acute Optic Neuropathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed for single-center open-label dose escalation phase I trial to evaluate the safety and tolerability of a singlemultiple intravitreal injection of FB1001 in patients with APACGAcute Primary Angle-Closure Glaucoma or NAIONNonarteritic Anterior Ischemic Optic Neuropathy
Detailed Description:
After acute attack of APACG or NAION patients are going to experience progression of visual field or visual acuity defects even after IOP or inflammation control by diverse treatments FB1001 is a recombinant humanized monoclonal antibody that protects and repairs the optic nerve thereby delaying the progression of glaucoma and NAION The main purpose of this study is to evaluate the safety and tolerability of FB1001 by singlemultiple intravitreal injections to Acute Optic Neuropathy Patients Pharmacokinetic profile through bloodAqueous will be investigated and preliminary efficacy will be explored if possible SADSingle Ascending Dose will consist of a maximum of 5 cohorts and each cohort will enroll 3 to 6 eligible patients MADMultiple Ascending Dose will consist of a maximum of 3 cohorts and each cohort will enroll 8 eligible patients For each participant the study will last up to about 12 weeks for SAD part and 24 weeks for MAD part
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