Clinical Study of FB1001 in Patients

NCT06506305 | Not Yet Recruiting Phase 1

• 1 other identifier: FB1001-03-101
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (18)

• AUC0-t

  Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks

• AUC0-∞

  Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks

• Cmax

  Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks

• Tmax

  Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks

• CL

  Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks

Study Arms (8)

SAD Cohort 1

EXPERIMENTAL

Participants in this cohort will receive SAD dose 1 of FB1001

Drug: FB1001

SAD Cohort 2

EXPERIMENTAL

Participants in this cohort will receive SAD dose 2 of FB1001

Drug: FB1001

SAD Cohort 3

EXPERIMENTAL

Participants in this cohort will receive SAD dose 3 of FB1001

Drug: FB1001

Experimental: SAD Cohort 4

EXPERIMENTAL

Participants in this cohort will receive SAD dose 4 of FB1001

Drug: FB1001

Experimental: SAD Cohort 5

EXPERIMENTAL

Participants in this cohort will receive SAD dose 5 of FB1001

Drug: FB1001

Experimental: MAD Cohort 1

EXPERIMENTAL

Participants in this cohort will receive MAD dose 1 of FB1001

Drug: FB1001

Experimental: MAD Cohort 2

EXPERIMENTAL

Participants in this cohort will receive MAD dose 2 of FB1001

Drug: FB1001

Experimental: MAD Cohort 3

EXPERIMENTAL

Participants in this cohort will receive MAD dose 3 of FB1001

Drug: FB1001

Interventions

FB1001 DRUG

Intravitreal (IVT) injection

Experimental: MAD Cohort 1; Experimental: MAD Cohort 2; Experimental: MAD Cohort 3; Experimental: SAD Cohort 4; Experimental: SAD Cohort 5; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• After successful treatment of the acute attack, the IOP of the study eye \<21 mmHg before dosing.
• Patients with Acute Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
• Positive diagnosis of NAION with symptom onset within 14 days prior to planned dosing with FB1001, refer to the diagnostic criteria as attached in protocol;
• Before drug administration, the BCVA score in the study eye by ETDRS is better than or equal to 15 letters.
• The use of corticosteroids remains stable before and after drug administration (Dose adjust determined by investigator, if needed).
• At least 40 years old;
• Sufficiently clear ocular media and adequate pupil dilation to allow observation and assessment of the optic nerve and macula in the study eye;
• Female subjects of childbearing potential, and male subjects with partners of childbearing potential, should agree to use effective contraception from the time of signing the informed consent form until 3 months after the last drug administration.

You may not qualify if:

• Patients with Acute Primary Angle-Closure Glaucoma (APACG) Optic Neuropathy:
• 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;
• History of optic neuritis or uveitis in any eye;
• Clinical evidence of temporal arteritis;
• History of collagen vascular disease or other inflammatory disease, or multiple sclerosis;
• Currently diagnosed with NAION in both eyes.
• The treatment with compound papaverine-like drugs is less than 5 half-lives from the administration of the study drug.
• The equivalent sphere of the refractive error in the study eye exceeds 6.0 diopters;
• The study eye has previously undergone subfoveal laser coagulation, vitrectomy, macular translocation surgery, or transpupillary thermotherapy;
• The study eye has undergone intraocular surgery (such as intraocular lens implantation, etc.) or periocular surgery within 90 days before drug administration, or eyelid surgery within 30 days before drug administration;
• The study eye has undergone YAG laser posterior capsulotomy within 28 days before drug administration;
• The study eye has received intraocular or peribulbar injection of corticosteroids (such as triamcinolone, etc.) within 6 months before screening;

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• 4B Technologies Limited: collaborator

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University

Shanghai, 200080, China

Location

MeSH Terms

Conditions

Optic Nerve Diseases; Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Glaucoma; Ocular Hypertension

Central Study Contacts

Xiaodong MD Sun, PhD

CONTACT

021-36126059; drsunxiaodong@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: July 17, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)