Optic NeuropathyPhase 1NCT06506305
Clinical Study of FB1001 in Patients
A Phase 1 study testing FB1001 in people with Optic Neuropathy and NAION - Non-Arteritic Ischemic Optic Neuropathy, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Optic Neuropathy, NAION - Non-Arteritic Ischemic Optic Neuropathy, APAC - Acute Primary Angle Closure
- What is being tested?
- FB1001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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;
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- 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 study eye has opacities of the refractive media or miosis that affect fundus examination, as judged by the investigator to be unsuitable for inclusion;
- The equivalent sphere of the refractive error in the study eye exceeds 6.0 diopters;
- The study eye has any ocular disease or past history that may affect vision and/or visual field other than acute angle-closure glaucoma and NAION [Vitreomacular traction syndrome, retinal detachment, Age-related macular degeneration, Retinal vein occlusion, Macular hole, Epiretinal membrane, Retinal pigment epithelial tear involving the macula, Diabetic retinopathy (except for mild non-proliferative diabetic retinopathy that does not require treatment), Optic neuritis, etc.], as judged by the investigator to be unsuitable for inclusion;
- 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;
- History of surgical procedure within 1 month before screening, and/or currently has unhealed wounds, ulcers, fractures, etc., and is judged by the investigator to be unsuitable for inclusion;
- The study eye has received intraocular or peribulbar injection of corticosteroids (such as triamcinolone, etc.) within 6 months before screening;
- Continuous use of systemic corticosteroids for more than 1 week within 90 days before drug administration (except for systemic steroid treatment for NAION before screening);
- Any eye has received any intravitreal anti-VEGF treatment (such as bevacizumab, aflibercept, etc.) within 90 days before drug administration;
- Any eye has a history of active ocular inflammation or infection within 30 days before drug administration;
- Presence of infectious diseases requiring systemic treatment (oral, intramuscular, or intravenous medication) before screening;
- Systemic application of nerve growth factor or BDNF-like treatment within 90 days before drug administration;
- Participation in any clinical trial for the treatment of optic neuropathy within 90 days before drug administration, with the exception of dietary supplements, vitamins, or minerals;
- Participation in any clinical trial within 60 days before drug administration;
- History of allergic reaction to fluorescein and indocyanine green, history of allergy to therapeutic or diagnostic biological products, or allergy to the study drug or its components.
- Currently using or likely to require systemic medication that may cause crystalline or retinal toxicity, such as deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazine, and ethambutol, etc.;
- History of myocardial infarction, unstable angina, coronary revascularization within 6 months before screening, cerebrovascular accident history (including TIA), other thromboembolic disease history (such as thromboangiitis, pulmonary embolism, deep vein thrombosis, portal vein thrombosis, etc.), New York Heart Association (NYHA) class ≥II heart failure, severe arrhythmia;
- Presence of systemic autoimmune diseases;
- Presence of disseminated intravascular coagulation and significant bleeding tendency (such as hemoptysis, hematemesis, severe purpura, etc.) within 3 months before screening, or having received anticoagulant or antiplatelet treatment other than aspirin/NSAIDs within 14 days before screening; Blood PLT ≤ 100 × 10^9/L, prothrombin time and activated partial thromboplastin time ≥ 3 seconds above the normal range (based on the normal values of the clinical trial institution's laboratory); taking antiplatelet drugs or anticoagulant drugs within 1 month before screening (patients taking a daily dose of aspirin ≤ 100mg are not included in this anticoagulant requirement, for patients taking aspirin, it is allowed to adjust the dose to 100mg and below on the day before screening to proceed with screening);
- Combined with severe liver and kidney diseases, or abnormal liver and kidney function during the screening period (ALT, AST ≥ 2.5 times the upper limit of the normal value; total bilirubin ≥ 1.5 times the upper limit of the normal value; creatinine, urea/blood urea nitrogen ≥ 1.2 times the upper limit of the normal value);
- Poorly controlled hypertension, defined as a single measurement of systolic blood pressure >180 mmHg, or two consecutive measurements of systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg (with a time interval of ≥30 minutes between measurements);
- Women who are already pregnant during the screening period, or are in the pregnancy or lactation period;
- Presence of active malignant tumors or a history of malignant tumors within 5 years before the baseline visit, except for completely cured in situ cervical cancer, and completely cured and regressed non-metastatic skin squamous cell carcinoma or basal cell carcinoma;
- History of mental illness, family history of mental illness, or emotional disorders as judged by the investigator or a psychiatrist;
- Other situations to be excluded judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai General Hospital, Shanghai Jiao Tong University
Shanghai, 200080
About this study
Official title: 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
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).
Read the 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
- Being tested
- FB1001
- Medical subject headings
- Optic Nerve Diseases, Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB1001Drug
Intravitreal (IVT) injection
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1 | Experimental | Participants in this cohort will receive SAD dose 1 of FB1001 Receives: Drug: FB1001 |
| SAD Cohort 2 | Experimental | Participants in this cohort will receive SAD dose 2 of FB1001 Receives: Drug: FB1001 |
| SAD Cohort 3 | Experimental | Participants in this cohort will receive SAD dose 3 of FB1001 Receives: Drug: FB1001 |
| Experimental: SAD Cohort 4 | Experimental | Participants in this cohort will receive SAD dose 4 of FB1001 Receives: Drug: FB1001 |
| Experimental: SAD Cohort 5 | Experimental | Participants in this cohort will receive SAD dose 5 of FB1001 Receives: Drug: FB1001 |
| Experimental: MAD Cohort 1 | Experimental | Participants in this cohort will receive MAD dose 1 of FB1001 Receives: Drug: FB1001 |
| Experimental: MAD Cohort 2 | Experimental | Participants in this cohort will receive MAD dose 2 of FB1001 Receives: Drug: FB1001 |
| Experimental: MAD Cohort 3 | Experimental | Participants in this cohort will receive MAD dose 3 of FB1001 Receives: Drug: FB1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAD phase: DLTs incidence
DLTs observed during the DLT observation period
Measured: within 28 days after dosing
SAD phase: Incidence of Treatment-Emergent Adverse Events
The percentages of subjects experiencing AEs will be calculated.
Measured: Baseline to 12 weeks
MAD phase: Incidence of Treatment-Emergent Adverse Events
The percentages of subjects experiencing AEs will be calculated.
Measured: Baseline to 24 weeks
Secondary outcomes (18)
AUC0-t
The area under the drug-time curve from 0 to time t
Measured: 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
Measured: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Cmax
The peak concentration
Measured: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Tmax
The peak time
Measured: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
CL
Clearance rate
Measured: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
t1/2
Half-life
Measured: 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
Measured: Baseline to 24 weeks
MAD phase: Cavg,ss
The average concentration in steady state
Measured: Baseline to 24 weeks
MAD phase: Rac
Accumulation Index
Measured: Baseline to 24 weeks
Immunogenicity evaluation indicators
Positive rate of anti-drug antibody. (neutralizing antibody, if needed)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start15 Aug 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuropathyStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 4B Technologies Limited
- Responsible party
- Principal investigator, Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506305
- Sponsor's protocol ID
- FB1001-03-101
- Status last verified
- Jul 2024
- First submitted
- 21 May 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the data is published, the IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06506305
- Acronym / sponsor ID
- FB1001-03-101
- Conditions
- Optic Neuropathy, NAION - Non-Arteritic Ischemic Optic Neuropathy, APAC - Acute Primary Angle Closure, Glaucoma, Angle-Closure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- 4B Technologies Limited
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort 1 | Experimental | Drug: FB1001Participants in this cohort will receive SAD dose 1 of FB1001 |
| SAD Cohort 2 | Experimental | Drug: FB1001Participants in this cohort will receive SAD dose 2 of FB1001 |
| SAD Cohort 3 | Experimental | Drug: FB1001Participants in this cohort will receive SAD dose 3 of FB1001 |
| Experimental: SAD Cohort 4 | Experimental | Drug: FB1001Participants in this cohort will receive SAD dose 4 of FB1001 |
| Experimental: SAD Cohort 5 | Experimental | Drug: FB1001Participants in this cohort will receive SAD dose 5 of FB1001 |
| Experimental: MAD Cohort 1 | Experimental | Drug: FB1001Participants in this cohort will receive MAD dose 1 of FB1001 |
| Experimental: MAD Cohort 2 | Experimental | Drug: FB1001Participants in this cohort will receive MAD dose 2 of FB1001 |
| Experimental: MAD Cohort 3 | Experimental | Drug: FB1001Participants in this cohort will receive MAD dose 3 of FB1001 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with Acute Primary Angle-Closure Glaucoma (APACG) Optic Neuropathy：
- Patients with Acute Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
- 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.
Key exclusion criteria (36 listed)
- Patients with Acute Primary Angle-Closure Glaucoma (APACG) Optic Neuropathy:
- Patients with Acute Non-arteritic Anterior Ischemic Optic Neuropathy (NAION):Intraocular pressure >24 mmHg in the study eye;
- The study eye has opacities of the refractive media or miosis that affect fundus examination, as judged by the investigator to be unsuitable for inclusion;
- The equivalent sphere of the refractive error in the study eye exceeds 6.0 diopters;
- The study eye has any ocular disease or past history that may affect vision and/or visual field other than acute angle-closure glaucoma and NAION [Vitreomacular traction syndrome, retinal detachment, Age-related macular degeneration, Retinal vein occlusion, Macular hole, Epiretinal membrane, Retinal pigment epithelial tear involving the macula, Diabetic retinopathy (except for mild non-proliferative diabetic retinopathy that does not require treatment), Optic neuritis, etc.], as judged by the investigator to be unsuitable for inclusion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FB1001Intravitreal (IVT) injection | Drug | 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 |
Primary outcome
SAD phase: DLTs incidence
Time frame: within 28 days after dosing
DLTs observed during the DLT observation period
SAD phase: Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline to 12 weeks
The percentages of subjects experiencing AEs will be calculated.
MAD phase: Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline to 24 weeks
The percentages of subjects experiencing AEs will be calculated.
18 secondary outcomes
AUC0-t
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
AUC0-∞
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Cmax
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Tmax
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
CL
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
t1/2
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
MAD phase: Cmin,ss
Time frame: Baseline to 24 weeks
MAD phase: Cavg,ss
Time frame: Baseline to 24 weeks
MAD phase: Rac
Time frame: Baseline to 24 weeks
Immunogenicity evaluation indicators
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Preliminary biological effects and efficacy evaluation indicator 1
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Preliminary biological effects and efficacy evaluation indicator 2
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Preliminary biological effects and efficacy evaluation indicator 3
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Preliminary biological effects and efficacy evaluation indicator 4
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Preliminary biological effects and efficacy evaluation indicator 5
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Preliminary biological effects and efficacy evaluation indicator 6
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Preliminary biological effects and efficacy evaluation indicator 7
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Preliminary biological effects and efficacy evaluation indicator 8
Time frame: Baseline to end of study, SAD up to 12 weeks and MAD up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No. After the data is published, the IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FB1001 in people with Optic Neuropathy and NAION - Non-Arteritic Ischemic Optic Neuropathy, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong MD Sun, PhD (021-36126059, drsunxiaodong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAD phase: DLTs incidence (time frame: within 28 days after dosing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.