This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Oral HX9428 tablets in patients with wet age-related macular degeneration(wAMD)
This is a Multicenter, Open-label, Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral HX9428 tablets in Subjects with Wet Age-related Macular Degeneration (wAMD). The study consists of 2 segments: Phase I and Phase II. Phase I will evaluate the safety and tolerability of HX9428 administered as single and multiple oral doses; dose escalation will follow a 3 + 3 design with overdose control. If evidence of efficacy is observed at any dose level during Phase I, a parallel Phase II study may be initiated while dose-escalation in Phase I continues. In Phase II, the daily dose of HX9428 will not exceed the Maximum Tolerated Dose (MTD) established in Phase I; dosing frequency will be once daily (QD) or every other day (QOD).The primary objective of Phase II is to assess the preliminary efficacy of HX9428 tablets under these regimens.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
198
Subjects will receive HX9428 orally every day. The total treatment period is tentatively set at 25 weeks..
Beijing Hospital
Beijing, China
RECRUITINGPhase I : Dose-Limiting Toxicity (DLT)
Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose
Time frame: Week 4
Phase II: Mean change of letters from baseline in Best Corrected Visual Acuity(BCVA)
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Time frame: week 25
Mean change from baseline in Central Subfield Thickness(CST)
Evaluated by Optical Coherence Tomography (OCT). The higher values means worse outcome.
Time frame: week 25
Proportion of patients gaining at least 15/10/5 letters from baseline in the BCVA
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Time frame: Week 25
Mean change from baseline in the total area of CNV and the total area of fluorescein leakage
Evaluated by Fundus Fluorescein Angiography (FFA)
Time frame: Week 25
Pharmacokinetic (PK) profile
Study the change of HX9428 drug concentration in the blood
Time frame: Week 4
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