AzTrials
AzTrials

Wet Age-related Macular Degeneration (AMD)Phase 1/2NCT07185841

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

A Phase 1/2 study testing HX9428 tablet in people with Wet Age-related Macular Degeneration (AMD), run by Fujian Haixi Pharmaceuticals Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 50 to 85 years
What is being tested?
HX9428 tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
1 siteChina
Study dates
1 Jul 2025to 7 Jan 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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) ;
  • Other protocol-specified inclusion criteria may apply

Who cannot join

  • 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;
Show all 16Show fewer
  • 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 %);
  • Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Junqing Li contact

+86 0591-87519936

junqing.li@hxpharma.com

China1 site, 1 recruiting

  • Beijing Hospital

    Beijing, 100010

    Hong Dai, 13910280398, Dai-hong@x263.net

    Recruiting

Other trials in China

About this study

Official title: 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)

This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Oral HX9428 tablets in patients with wet age-related macular degeneration(wAMD)

Read the 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.

Being tested
HX9428 tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HX9428 tabletDrug

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

Study groups in NCT07185841
Study groupRoleWhat they receive
HX9428 tabletExperimentalEscalating dose of HX9428 tablet starting at 5mg once a day.
Receives: Drug: HX9428 tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 4

  2. 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.

    Measured: week 25

Secondary outcomes (4)

  1. Mean change from baseline in Central Subfield Thickness（CST）

    Evaluated by Optical Coherence Tomography (OCT). The higher values means worse outcome.

    Measured: week 25

  2. Proportion of patients gaining at least 15/10/5 letters from baseline in the 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.

    Measured: Week 25

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

    Evaluated by Fundus Fluorescein Angiography (FFA)

    Measured: Week 25

  4. Pharmacokinetic (PK) profile

    Study the change of HX9428 drug concentration in the blood

    Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start1 Jul 2025
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion7 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07185841
Sponsor's protocol ID
HXP056-CTPI-01
Status last verified
Oct 2026
First submitted
15 Sep 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HX9428 tablet in people with Wet Age-related Macular Degeneration (AMD), run by Fujian Haixi Pharmaceuticals Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Junqing Li (+86 0591-87519936, junqing.li@hxpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I : Dose-Limiting Toxicity (DLT) (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07185841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in