The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)
This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.
- EligibilityCriteria: Inclusion Criteria:  Subjects may be enrolled in this study only if they satisfy all the following criteria:  Adult male or female subjects ≥18 years of age Diagnosis of ITP, with a duration of disease of at least 3 months prior to randomization or enrollment Intolerance or insufficient response or recurrence after at least 1 prior ITP treatment (excluding splenectomy) Response (defined as achieved a platelet count ≥50 × 109/L) to at least 1 prior ITP therapy (including splenectomy) Adequate hematologic, hepatic and renal function  Exclusion Criteria:  Subjects are not eligible for enrollment into this study if any one of the following criteria are met:  Evidence of the presence of secondary causes of ITP Clinically serious hemorrhage requiring immediate adjustment of platelets Known history of vital organ transplantation or hematopoietic stem-cell transplantation or chimeric antigen receptor T-cells (CAR-T) therapy Splenectomy within 12 weeks prior to enrollment Presence of active malignancy unless deemed cured by adequate treatment. History of serious cardiovascular disease corrected QT interval (QTcF) ≥450 ms Uncontrolled hypertension Being unsuitable to participate in this study as considered by investigators - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult