Clinical Study of FB1001 in Patients
NCT Number: NCT06506305
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Optic Neuropathy|NAION - Non-Arteritic Ischemic Optic Neuropathy|APAC - Acute Primary Angle Closure|Glaucoma, Angle-Closure
Interventions: DRUG: FB1001
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators: 4B Technologies Limited
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 59
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2026-10-31
Locations: Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, 200080, China

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).

Primary Outcome Measures: SAD phase: DLTs incidence, DLTs observed during the DLT observation period, within 28 days after dosing|SAD phase: Incidence of Treatment-Emergent Adverse Events, The percentages of subjects experiencing AEs will be calculated., Baseline to 12 weeks|MAD phase: Incidence of Treatment-Emergent Adverse Events, The percentages of subjects experiencing AEs will be calculated., Baseline to 24 weeks
Secondary Outcome Measures: AUC0-t, The area under the drug-time curve from 0 to time t, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|AUC0-∞, The area under the curve at the time of 0-infinity, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|Cmax, The peak concentration, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|Tmax, The peak time, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|CL, Clearance rate, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|t1/2, Half-life, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|MAD phase: Cmin,ss, The trough concentration in steady state, Baseline to 24 weeks|MAD phase: Cavg,ss, The average concentration in steady state, Baseline to 24 weeks|MAD phase: Rac, Accumulation Index, Baseline to 24 weeks|Immunogenicity evaluation indicators, Positive rate of anti-drug antibody. (neutralizing antibody, if needed), Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|Preliminary biological effects and efficacy evaluation indicator 1, Anatomical changes in optic nerve head by OCT compared with baseline/fellow eyes, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|Preliminary biological effects and efficacy evaluation indicator 2, Changes in RNFL thickness by OCT with baseline/fellow eyes, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|Preliminary biological effects and efficacy evaluation indicator 3, Changes in GCC by OCT compared with baseline/fellow eyes, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|Preliminary biological effects and efficacy evaluation indicator 4, Changes in blood flow density of optic disc by OCTA with baseline/fellow eyes, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|Preliminary biological effects and efficacy evaluation indicator 5, Changes in blood flow density of macula by OCTA with baseline/fellow eyes, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|Preliminary biological effects and efficacy evaluation indicator 6, Changes in BCVA/Visual Field compared with baseline, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|Preliminary biological effects and efficacy evaluation indicator 7, Changes in P-VEP(pattern-visual evoked potential)compared with baseline, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks|Preliminary biological effects and efficacy evaluation indicator 8, Changes in P-ERG compared with baseline, Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks