Recruiting

HX9428 Tablets for Wet Age-related Macular Degeneration

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What is being tested

HX9428 tablet

Drug
Who is being recruted

From 50 to 85 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorFujian Haixi Pharmaceuticals Co., Ltd.
Study ContactJunqing Li
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2025

Actual date on which the first participant was enrolled.

The study focuses on testing an oral medication called HX9428 to help people with Wet Age-related Macular Degeneration (wAMD), a common eye condition that can cause vision loss. The goal is to determine if this medication is safe and effective for people suffering from this condition. By conducting this study, researchers hope to find a new treatment option that is easier to administer and potentially less invasive than current treatments. Participants in this study will take HX9428 tablets by mouth. The study has two main parts: Phase I, where the safety of different dosages is tested, and Phase II, which looks at how well the medication works at the safest dose found in Phase I. During the first phase, the dosage may be increased gradually to find the most suitable level without causing adverse effects. If the medication shows promising results in the first phase, the study may move to the second phase, focusing on effectiveness. Monitoring will ensure participant safety and help determine the best dosing schedule for future treatments.

Official TitleA 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)
NCT07185841
Principal SponsorFujian Haixi Pharmaceuticals Co., Ltd.
Study ContactJunqing Li
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

198 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * Participants must meet the following criteria for study entry: 1. 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; 2. 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 ; 3. 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; 4. ETDRS BCVA 19 to 78 letters in the study eyes( corresponding to a Snellen equivalent of approximately 20/32 to 20/400) ; 5. Other protocol-specified inclusion criteria may apply Exclusion Criteria: * Subjects who meet any of the following criteria will be excluded from this study: 1. Subjects diagnosed with polypoidal choroidal vasculopathy by Indocyanine Green(ICG) angiography who are at high risk of massive hemorrhage; 2. 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; 3. CNV due to causes other than AMD; 4. Any condition in the study eye that could compromise best-corrected visual acuity; 5. Active ocular inflammation or infection in either eye or a history of idiopathic or autoimmune-related uveitis; 6. Refractive error exceeding -6.00 D spherical equivalent; 7. Ocular surgery performed in the study eye within 90 days before screening; 8. Previous treatment with photodynamic therapy (within 120 days of screening), external-beam radiotherapy, macular laser photocoagulation, macular surgery, or transpupillary thermotherapy; 9. Systemic anti-VEGF therapy administered within 90 days before the first dose; 10. Pregnant or lactating women; 11. Known hypersensitivity or contraindication to any study-related procedure drugs; 12. 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; 13. Stroke within 12 months or transient ischemic attack within 6 months of enrolment; 14. Poorly controlled diabetes (HbA1c ≥ 12 %); 15. Other protocol-specified exclusion criteria may apply.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Escalating dose of HX9428 tablet starting at 5mg once a day.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Beijing Hospital

Beijing, ChinaOpen Beijing Hospital in Google Maps
Recruiting
One Study Center
HX9428 Tablets for Wet Age-related Macular Degeneration | PatLynk