NCT06291415

The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)

A Multicenter, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523, a Syk Inhibitor, in Adult Subjects With Immune Thrombocytopenia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.

Detailed description

This study is a Phase 1b, open-label, multicenter, single-arm study to evaluate the safety, tolerability, and preliminary efficacy of HMPL-523 in adult subjects with primary ITP diagnosed at least 3 months prior to enrollment or randomization. In the dose escalation stage (Part 1), subjects will receive one of 3 dose levels of HMPL-523 to determine the recommended dose of HMPL-523 for the randomized dose optimization- stage (Part 2). At the end of Part 1, 2 dose levels will be selected to be used in the dose-optimization stage (Part 2) of the study. In Part 2 of the study, subjects will be randomized in a 1:1 ratio between the 2 dose levels to better understand the exposure/efficacy/toxicity relationship. At the end of Part 2, the Recommended Phase 3 dose (RP3D) of HMPL-523 will be determined based on the safety, efficacy and PK data.

Conditions

• Immune Thrombocytopenia
• Blood Platelet Disorder
• Hematologic Diseases
• Purpura, Thrombocytopenic
• Purpura
• Blood Coagulation Disorder
• Thrombotic Microangiopathies
• Hemorrhagic Disorders
• Autoimmune Diseases
• Immune System Diseases
• Hemorrhage
• Pathologic Processes
• Skin Manifestations
• Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Primary Immune Thrombocytopenia
• ITP - Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	HMPL-523	Syk inhibitor

Timeline

• Start date: 2024-04-02
• Primary completion: 2026-04-01
• Completion: 2026-11-01
• First posted: 2024-03-04
• Last updated: 2025-09-16

Locations

28 sites across 5 countries: United States, Australia, Germany, Norway, Spain

Regulatory

• FDA-regulated drug study