NCT04747964

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

A Phase 1,Multi-center, Randomized, Open, Single-dose Escalation Design to Evaluate the Safety, Tolerability and Pharmacodynamics of STSP-0601 for Injection in Patients With Inhibitory Hemophilia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia

Interventions

Type	Name	Description
DRUG	STSP-0601 for Injection	Subjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements
DRUG	STSP-0601 for Injection	Subjects will receive one single low dose of STSP-0601 for Injection following protocol requirements
DRUG	STSP-0601 for Injection	Subjects will receive one single low-intermediate dose of STSP-0601 for Injection following protocol requirements
DRUG	STSP-0601 for Injection	Subjects will receive one single intermediate dose of STSP-0601 for Injection following protocol requirements
DRUG	STSP-0601 for Injection	Subjects will receive one single high dose of STSP-0601 for Injection following protocol requirements
DRUG	STSP-0601 for Injection	Subjects will receive one single highest dose of STSP-0601 for Injection following protocol requirements

Timeline

• Start date: 2020-01-15
• Primary completion: 2021-04-19
• Completion: 2021-04-19
• First posted: 2021-02-10
• Last updated: 2024-09-19

Locations

1 site across 1 country: China