NCT07185841

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

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Fujian Haixi Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	HX9428 tablet	Subjects will receive HX9428 orally every day. The total treatment period is tentatively set at 25 weeks..

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-07-01
• Completion: 2029-01-07
• First posted: 2025-09-22
• Last updated: 2025-09-25

Locations

1 site across 1 country: China