NCT07185841 Safety and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD)
| NCT ID | NCT07185841 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Fujian Haixi Pharmaceuticals Co., Ltd. |
| Condition | Wet Age-related Macular Degeneration (AMD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 198 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 198 participants in total. It began in 2025-07-01 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Hong Dai
PRINCIPAL INVESTIGATOR
Beijing Hospital
Frequently Asked Questions
Who can join the NCT07185841 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Wet Age-related Macular Degeneration (AMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07185841 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07185841 currently recruiting?
Yes, NCT07185841 is actively recruiting participants. Contact the research team at junqing.li@hxpharma.com for enrollment information.
Where is the NCT07185841 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07185841 clinical trial?
NCT07185841 is sponsored by Fujian Haixi Pharmaceuticals Co., Ltd.. The principal investigator is Hong Dai at Beijing Hospital. The trial plans to enroll 198 participants.