This study is designed as a Multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injections of IBI324 in subjects with DME
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Safety evaluation indicators
Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events b) Changes in central subfield thickness by OCT compared with baseline
Time frame: Through study completion, a maximum of 24 weeks
The incidence of adverse events
Time frame: Through study completion, a maximum of 24 weeks
Changes in visual acuity as measured by BCVA compared with baseline
Time frame: Through study completion, a maximum of 24 week
Changes in the average thickness of the macula in the central 1 mm ETDRS grid (CST) compared with baseline
Time frame: Through study completion, a maximum of 24 week
Pharmacokinetic (PK) profiles, such as half-life time (t1/2),etc
Positive rate of anti-drug antibody
Time frame: Through study completion, a maximum of 24 weeks
Immunogenicity evaluation indicators
Positive rate of anti-drug antibody
Time frame: Through study completion, a maximum of 24 weeks
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Dose 3 IBI324 of single IVT injection
Dose 3 IBI324 of multiple IVT injection