RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing HX9428 tablet for Wet Age-related Macular Degeneration (AMD)

This study will measure the safety, tolerability, pharmacokinetics and preliminary how well it works of Oral HX9428 tablets in patients with wet age-related macular degeneration(wAMD)

Official registry: https://clinicaltrials.gov/study/NCT07185841 · Fujian Haixi Pharmaceuticals Co., Ltd. · enrollment listed as 198

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are HX9428 tablet. The registry lists allocation as na. This study will measure the safety, tolerability, pharmacokinetics and preliminary how well it works of Oral HX9428 tablets in patients with wet age-related macular degeneration(wAMD)

They plan to enroll about 198 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: HX9428 tablet

Primary outcome (registry wording): Phase I : Dose-Limiting Toxicity (DLT)

Who it is for (from inclusion criteria)

Ages 50 Years to 85 Years
Participants must meet the following criteria for study entry:
Treatment-who have not tried this kind of treatment before , 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 who can join may apply

Who the registry excludes

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;

Public study contact (from the registry)

Junqing Li

+86 0591-87519936

junqing.li@hxpharma.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Beijing Hospital — Beijing, China (recruiting)

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FAQ about this NCT record

Is NCT07185841 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07185841?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07185841?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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