NCT05639530CompletedPhase 1
A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI333 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country17 target enrollmentStarted: February 27, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Safety and tolerance indicators
Study Overview
Brief Summary
This study is designed for multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of IBI333 in subjects with neovascular age-related macular degeneration (nAMD).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
- •Male or female patients ≥ 50 yrs. of age.
- •Active CNV lesions secondary to neovascular AMD.
- •BCVA score of 19-78 letters using ETDRS charts in the study eye.
- •Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 6 months after the end of treatment.
Exclusion Criteria
- •Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
- •Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye;
- •Active ocular or periocular inflammation/infection in either eye;
- •Prior any treatment of following in the study eye:
- •Anti-VEGF therapy within 90 days prior to screening;
- •Intraocular glucocorticoid injection within 180 days prior to screening;
- •Laser photocoagulation or photodynamic therapy within 90 days prior to screening;
- •Intraocular surgery within 90 days prior to screening;
- •Laser posterior capsulotomy, laser trabeculectomy or laser peripheral iridectomy within 30 days prior to screening;
- •Glycated hemoglobin (HbA1c) > 8% within 28 days prior to screening;
- •Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg);
- •Systemic administration of steroids within 30 days prior to screening;
- •Systemic administration of anti-VEGF drugs within 90 days prior to screening;
- •History of severe hypersensitivity/allergic to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
- •Participated in any clinical study of any other drug within 90 days prior to enrollment, or attempted to participate in other drug trials during the study;
- •Other conditions unsuitable for enrollment judged by investigators.
Arms & Interventions
:treated with different doses of single intravitreal injections of IBI333
Experimental
Biological: IBI333 Dose 1 IBI333 of single IVT injections，
Biological: IBI333 Dose 2 IBI333 of single IVT injections
Intervention: IBI333 (Biological)
treated with different doses of multiple intravitreal injections of IBI333
Experimental
Biological: IBI333 Dose 3 IBI333 of multiple IVT injections，
Biological: IBI333 Dose 4 IBI333 of multiple IVT injections
Intervention: IBI333 (Biological)
Outcomes
Primary Outcomes
Safety and tolerance indicators
Time Frame: Through study completion, a maximum of 24 weeks
1. Incidence, relatedness and severity of all adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE); 2. Incidence of dose limiting toxicity;
Secondary Outcomes
- Maximum concentration (Cmax) of the drug after the administration.(Through study completion, a maximum of 24 weeks)
- Time at which maximum concentration (Tmax) occurs for the drug after the administration.(Through study completion, a maximum of 24 weeks)
- Number of participants with anti-drug antibodies or neutralizing antibodies .(Through study completion, a maximum of 24 weeks)
- Changes of CST measured by spectral domain optical coherence tomography (SD-OCT) from baseline.(Through study completion, a maximum of 24 weeks)
- The area under the curve (AUC) of serum concentration of the drug after the administration.(Through study completion, a maximum of 24 weeks)
- The half-life (t1/2) of drug after the administration .(Through study completion, a maximum of 24 weeks)
- Changes of BCVA measured by ETDRS chart from baseline.(Through study completion, a maximum of 24 weeks)
- Proportion of subjects without intraretinal or subretinal fluid on SD-OCT.(Through study completion, a maximum of 24 weeks)
- Change of height of pigment epithelial detachment from baseline on SD-OCT.(Through study completion, a maximum of 24 weeks)
Investigators
Study Sites (1)
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