This is a Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Intermittent Oral Dosing of CM082 tablets in Chinese Patients With mCNV.
This is a multicenter, open-label, single-arm, phase I Study to Evaluate the safety, tolerability, pharmacokinetics and preliminary Efficacy of intermittent oral dosing of CM082 tablets in Chinese patients with mCNV. The study will be performed in two different parts, dose-escalation phase (Part 1) and dose-expansion phase (Part 2). Subjects will receive CM082 orally for two weeks followed by two weeks off in four-week cycles. There are three dose levels, 25mg BID,50mg QD and 50mg BID. The total treatment period is tentatively set at 3 cycles (12 weeks). Based on data from dose escalation studies, identify safe and effective doses for expanded enrollment studies.The assessment of the safety and efficacy will be done in 2、4、8、12weeks after the first dose.Also, single/multiple dose pharmacokinetics in these patients will be studied.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Subjects will receive CM082 orally for two weeks followed by two weeks off in four-week cycles.The total treatment period is tentatively set at 3 cycles (12 weeks).
Peking Union Medical College Hospital
Beijing, China
Dose-Limiting Toxicity(DLT)
Any serious adverse event in eye or any ≥3 grade adverse reactions cannot be reduced to below grade 3 after treatment for more than 7 days.
Time frame: the first cycle(the first four weeks)
Adverse event
Incidence of the adverse event after treatment
Time frame: 12 weeks
Change in Best-Corrected Visual Acuity (BCVA)
Change from baseline in mean BCVA (ETDRS)
Time frame: 12 weeks
Change in Choroidal Neovascularization (CNV) size
Change from baseline in mean CNV size (FA)
Time frame: 12 weeks
Change in Central Retinal Thickness
Change from baseline in mean central retinal thickness (OCT)
Time frame: 12 weeks
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