Safety and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD)

NCT ID: NCT07185841

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2029-01-07

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)

Detailed Description

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.

Conditions

Wet Age-related Macular Degeneration (AMD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HX9428 tablet

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

Group Type: EXPERIMENTAL

HX9428 tablet

Intervention Type: DRUG

Subjects will receive HX9428 orally every day. The total treatment period is tentatively set at 25 weeks..

Interventions

HX9428 tablet

Subjects will receive HX9428 orally every day. The total treatment period is tentatively set at 25 weeks..

Intervention Type: DRUG

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) ;

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 %);

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Haixi Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hong Dai

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital

Locations

Beijing Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Junqing Li

Role: CONTACT

junqing.li@hxpharma.com

+86 0591-87519936

Facility Contacts

Hong Dai

Role: primary

Dai-hong@x263.net

13910280398

Other Identifiers

HXP056-CTPI-01

Identifier Type: -

Identifier Source: org_study_id