Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HMPL-523 · 11 trials · 9 indications
Platelet count ≥50×10\^9 /L on at least 4 of 6 scheduled visits of Week14-Week24 in the primary study
Phase II: Overall Hb response rate: the proportion of patients with overall Hb response by Week 24
Adverse Events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Incidence of dose limited toxicities and associated dose of HMPL-523
To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects
To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects
To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects
To evaluate the pharmacokinetics and bioequivalence of HMPL- 523 Tablets 300 mg (100 mg/tablet×3) (produced by two different manufacturers) taken orally in a single dose after a standard meal in healthy Chinese subjects
| Arm | Type | Description |
|---|---|---|
| Drug: HMPL-523 | ACTIVE_COMPARATOR | Primacy study (Randomized, Double-Blind Phase): Eligible subjects receive 300 mg HMPL-523 treatment once daily for 24 weeks. Sub study (Open-label Phase): Eligible subjects receive 300 mg HMPL-523 treatment once daily for 76 weeks after the enrollment of the last patient enrolled in open-label phase. |
| Drug: placebo | PLACEBO_COMPARATOR | Primacy study (Randomized, Double-Blind Phase): Eligible subjects will receive 300 mg HMPL-523 matched placebo treatment once daily for 24 weeks. |
| HMPL-523 | EXPERIMENTAL | Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment. Phase III: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks and enter open-label phase in the opinion of the Investigator. |
| Placebo | PLACEBO_COMPARATOR | Phase II: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 8 weeks and at least 16 weeks open-label treatment. Phase III: Eligible subjects will receive 300 mg HMPL-523 treatment once daily for 24 weeks and enter open-label phase in the opinion of the Investigator. |
| treatment arm | ACTIVE_COMPARATOR | Eligible subjects will be treated with planned dose of 100 mg, 200 mg and 300 mg HMPL-523 once daily for 8 weeks and 16 weeks open-label treatment. |
| placebo arm | PLACEBO_COMPARATOR | Eligible subjects will be treated with HMPL-523 matching placebo once daily for 8 weeks and 16 weeks open-label treatment. |
| HMPL-523-TRR | EXPERIMENTAL | Three cycle dose: TRR Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA |
| HMPL-523-RTR | EXPERIMENTAL | Three cycle dose:RTR Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA |
| HMPL-523-RRT | EXPERIMENTAL | Three cycle dose:RRT Test product: HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Co., Ltd.; Reference product: HMPL-523 Tablets manufactured by WuXi STA |
| Name | Type | Description |
|---|---|---|
| HMPL-523 | DRUG | HMPL-523(300mg PO QD) |
| Placebo | DRUG | Placebo(300mg PO QD) |
| HMPL-523(300mg PO QD) | DRUG | HMPL-523(300mg PO QD) |
| HMPL-523 Acetate Tablets (Test Formulation) | DRUG | The trial participants were administered the drug on the first day of each cycle. dose 300mg |
| HMPL-523 Acetate Tablets (Reference Formulation) | DRUG | The trial participants were administered the drug on the first day of each cycle. dose 300mg |
| 150 µCi [14C]HMPL-523 | DRUG | D8: \[14C\] HMPL-523 Suspension 300 mg/150 μCi Single dose |
| Itraconazole | DRUG | Itraconazole is an FDA approved synthetic triazole antifungal agent |
| Rifampin | DRUG | Rifampin is an FDA approved semisynthetic antiobiotic derivative indicated in the treatment of both tuberculosis and meningococcal carrier state |
| Rabeprazole | DRUG | 40 mg of rabeprazole will be administered by mouth once daily in the morning from Day 20 to Day 26 |
Inclusion Criteria for double-blind phase: 1. Voluntary signature of written informed consent form; 2. Male or female aged 18\~75 years; 3. Performance Status score \[Eastern Cooperative Oncology Group (ECOG) score\] 0\~1; 4. Having been diagnosed as ITP prior to randomization, and duration of dise...