RecruitingPhase 1Phase 2NCT07185841
Safety and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD)
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)
Sponsor
Fujian Haixi Pharmaceuticals Co., Ltd.
Enrollment
198 participants
Start Date
Jul 1, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Oral HX9428 tablets in patients with wet age-related macular degeneration(wAMD)
Eligibility
Min Age: 50 YearsMax Age: 85 Years
Inclusion Criteria5
- Participants must meet the following criteria for study entry:
- Age ≥50 years and ≤80 years (Phase I), Age ≥50 years and ≤85 years (Phase II) at the time of signing informed consent, male or female;
- Active choroidal neovascularization (CNV) secondary to AMD, as evidenced on fluorescein fundus angiography (FFA) and optical coherence tomography (OCT) (Active CNV is defined as the presence of subretinal or intraretinal fluid or leakage); A total lesion size of <12 disc areas on FFA ;
- Treatment-naive , or previous anti-VEGF treatment that was effective and discontinued for more than 3 months, with OCT evidence of subretinal fluid or cystoid macular edema;
- ETDRS BCVA 19 to 78 letters in the study eyes( corresponding to a Snellen equivalent of approximately 20/32 to 20/400) ;
Exclusion Criteria15
- Subjects who meet any of the following criteria will be excluded from this study:
- Subjects diagnosed with polypoidal choroidal vasculopathy by Indocyanine Green(ICG) angiography who are at high risk of massive hemorrhage;
- On FFA/CFP: subretinal hemorrhage of >50 % of the total lesion area or that involves the fovea; fibrosis or atrophy of >50 % of the total lesion area or that involves the fovea;
- CNV due to causes other than AMD;
- Any condition in the study eye that could compromise best-corrected visual acuity;
- Active ocular inflammation or infection in either eye or a history of idiopathic or autoimmune-related uveitis;
- Refractive error exceeding -6.00 D spherical equivalent;
- Ocular surgery performed in the study eye within 90 days before screening;
- Previous treatment with photodynamic therapy (within 120 days of screening), external-beam radiotherapy, macular laser photocoagulation, macular surgery, or transpupillary thermotherapy;
- Systemic anti-VEGF therapy administered within 90 days before the first dose;
- Pregnant or lactating women;
- Known hypersensitivity or contraindication to any study-related procedure drugs;
- History of severe cardiac disease, symptomatic congestive heart failure, unstable angina, acute coronary syndrome, myocardial infarction, coronary revascularization, thrombotic event, or bleeding episode within 6 months prior to the start of study drug, uncontrolled hypertension (systolic blood pressure> 150 mmHg and/or diastolic blood pressure > 100 mmHg on optimal medical therapy), or ventricular arrhythmia requiring ongoing treatment;
- Stroke within 12 months or transient ischemic attack within 6 months of enrolment；
- Poorly controlled diabetes (HbA1c ≥ 12 %);
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Interventions
DRUGHX9428 tablet
Subjects will receive HX9428 orally every day. The total treatment period is tentatively set at 25 weeks..
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07185841