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

NCT07185841 | Recruiting Phase 1

• 1 other identifier: HXP056-CTPI-01
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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)

Conditions

Wet Age-related Macular Degeneration (AMD)

Outcome Measures

Primary Outcomes (2)

• Phase 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

  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.

  week 25

Secondary Outcomes (4)

• Mean change from baseline in Central Subfield Thickness（CST）

  week 25

• Proportion of patients gaining at least 15/10/5 letters from baseline in the BCVA

  Week 25

• Mean change from baseline in the total area of CNV and the total area of fluorescein leakage

  Week 25

• Pharmacokinetic (PK) profile

  Week 4

Study Arms (1)

HX9428 tablet

EXPERIMENTAL

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

Drug: HX9428 tablet

Interventions

HX9428 tablet DRUG

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

HX9428 tablet

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) ;

You may not qualify if:

• 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 %);

Sponsors & Collaborators

• Fujian Haixi Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, 100010, China

RECRUITING

Study Officials

• Hong Dai

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junqing Li

CONTACT

+86 0591-87519936; junqing.li@hxpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 7, 2029
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)