A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor

Phase 1 Completed 16 enrolled Staidson (Beijing) Biopharmaceuticals Co., Ltd

RandomizedSequentialOpen-labelTreatment

Summary

This study will assess the pharmacokinetics and pharmacodynamics of STSP-0601 at six dose levels. The results will help identify the most optimal doses to treat bleedings in hemophilia patients with inhibitors.

Timeline

Start: 2020-01-15
Primary completion: 2021-04-19
Completion: 2021-04-19

Publications

Liu W, Xue F, Fu R, Ding B, Li M, Sun T, Chen Y, Liu X, Ju M, Dai X, Wu Q, Zhou Z, Yu J, Wang X, Zhu Q, Zhou H, Yang R, Zhang L. Preclinical studies of a factor X activator and a phase 1 trial for hemophilia patients with inhibitors. J Thromb Haemost. 2023 Jun;21(6):1453-1465. doi: 10.1016/j.jtha.2023.01.040. Epub 2023 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	bemiltenase alfa	Protein / enzyme biologic	0.01 iu/kg	Intravenous
Subject	bemiltenase alfa	Protein / enzyme biologic	0.04 iu/kg	Intravenous
Subject	bemiltenase alfa	Protein / enzyme biologic	0.08 iu/kg	Intravenous
Subject	bemiltenase alfa	Protein / enzyme biologic	0.16 iu/kg	Intravenous
Subject	bemiltenase alfa	Protein / enzyme biologic	0.32 iu/kg	Intravenous
Subject	bemiltenase alfa	Protein / enzyme biologic	0.48 iu/kg	Intravenous

A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor

Summary

Timeline

Publications

Drugs

Indications