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).
Patients with Acute Primary Angle-Closure Glaucoma (APACG) Optic Neuropathy：
Within 120 hours prior to the planned administration of the study drug, the study eye has the initial symptoms of an acute attack of primary angle closure; refer to the diagnostic criteria as attached in protocol;
The symptom duration of the acute attack ≥1 day, and the experienced highest intraocular pressure (IOP) in the study eye ≥30 mmHg;
After acute attack is controlled, the BCVA in the study eye is 20/40 or higher;
History or current diagnosis of glaucoma in both eyes;
History of chronic primary angle-closure glaucoma in any eye;
History of secondary angle-closure glaucoma in any eye.
Patients with Acute Non-arteritic Anterior Ischemic Optic Neuropathy (NAION):Intraocular pressure >24 mmHg in the study eye;
Single group
FB1001
DrugIntravitreal (IVT) injection
8
Treatment groupsSee each treatment group below.
SAD phase: DLTs incidence
DLTs observed during the DLT observation period
SAD phase: Incidence of Treatment-Emergent Adverse Events
The percentages of subjects experiencing AEs will be calculated.
MAD phase: Incidence of Treatment-Emergent Adverse Events
The percentages of subjects experiencing AEs will be calculated.
AUC0-t
The area under the drug-time curve from 0 to time t
AUC0-∞
The area under the curve at the time of 0-infinity
Cmax
The peak concentration
Tmax
The peak time
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor
4B Technologies Limited
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
