Delving into the Latest Updates on HX9428 with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

HX9428

Target-

Action-

Mechanism-

Therapeutic Areas

Congenital DisordersEye Diseases

Active Indication

Wet age-related macular degeneration

Inactive Indication-

Originator Organization

Fujian Haixi New Drug Creation Co., Ltd.

Active Organization

Fujian Haixi New Drug Creation Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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I期研究：主要目的：确定HX9428片在治疗wAMD患者中口服的最大耐受剂量（MTD）、II期试验推荐剂量（RP2D）、剂量限制性毒性（DLT）和安全性。次要目的：考察HX9428片在wAMD患者中单、多次口服给药的药代动力学（PK）特征；初步观察HX9428片在wAMD患者中的疗效。 II期研究：主要目的：初步观察HX9428片在wAMD患者中的安全性和疗效。次要目的：评价HX9428片在wAMD患者中的药代动力学（PK）特征。

[Translation]

Phase I study: Primary objective: To determine the maximum tolerated dose (MTD), Phase II trial recommended dose (RP2D), dose-limiting toxicity (DLT) and safety of HX9428 tablets for oral administration in patients with wAMD. Secondary objective: To investigate the pharmacokinetic (PK) characteristics of HX9428 tablets after single and multiple oral administration in patients with wAMD; to preliminarily observe the efficacy of HX9428 tablets in patients with wAMD. Phase II study: Primary objective: To preliminarily observe the safety and efficacy of HX9428 tablets in patients with wAMD. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of HX9428 tablets in patients with wAMD.

Start Date-

Sponsor / Collaborator

Fujian Haixi New Drug Creation Co., Ltd.

100 Clinical Results associated with HX9428

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100 Translational Medicine associated with HX9428

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100 Patents (Medical) associated with HX9428

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100 Deals associated with HX9428

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