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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评估Bruton酪氨酸激酶(BTK)抑制剂SS-001在B细胞淋巴瘤患者的安全性、耐受性、药代动力学特征及有效性的I期临床研究
[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and efficacy of the Bruton's tyrosine kinase (BTK) inhibitor SS-001 in patients with B-cell lymphoma
主要目的:1)评估SS-001在B细胞淋巴瘤患者中的安全性及耐受性。2)评估SS-001的最大耐受剂量(MTD)及II期临床推荐剂量(RP2D)。
次要目的:1)评价单次和多次口服SS-001在B细胞淋巴瘤患者中的人体药代动力学(PK)特征。2)评估SS-001在外周血单核细胞(PBMCs)中BTK靶点占据程度。3)初步评价SS-001在B细胞淋巴瘤患者中的有效性。
[Translation] Primary objectives: 1) To evaluate the safety and tolerability of SS-001 in patients with B-cell lymphoma. 2) To evaluate the maximum tolerated dose (MTD) and recommended dose (RP2D) of SS-001 for Phase II clinical trials.
Secondary objectives: 1) To evaluate the human pharmacokinetic (PK) characteristics of single and multiple oral SS-001 in patients with B-cell lymphoma. 2) To evaluate the BTK target occupancy of SS-001 in peripheral blood mononuclear cells (PBMCs). 3) To preliminarily evaluate the efficacy of SS-001 in patients with B-cell lymphoma.
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