NCT06506305

Clinical Study of FB1001 in Patients

A Single/Multiple 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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study is designed for single-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single/multiple intravitreal injection of FB1001 in patients with APACG(Acute Primary Angle-Closure Glaucoma) or NAION(Nonarteritic 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 single/multiple intravitreal injections to Acute Optic Neuropathy Patients. Pharmacokinetic profile through blood/Aqueous will be investigated and preliminary efficacy will be explored if possible. SAD(Single Ascending Dose) will consist of a maximum of 5 cohorts and each cohort will enroll 3 to 6 eligible patients. MAD(Multiple 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.

Conditions

• Optic Neuropathy
• NAION - Non-Arteritic Ischemic Optic Neuropathy
• APAC - Acute Primary Angle Closure
• Glaucoma, Angle-Closure

Interventions

Type	Name	Description
DRUG	FB1001	Intravitreal (IVT) injection

Timeline

• Start date: 2024-08-15
• Primary completion: 2026-06-30
• Completion: 2026-10-31
• First posted: 2024-07-17
• Last updated: 2024-07-17

Locations

1 site across 1 country: China