NCT04768699

Study of Recombinant Human Coagulation Factor VIIa for Injection (FⅦa) in Patients With Hemophilia.

A Dose-ascending Study to Evaluate the Pharmacokinetics and Pharmacodynamics (PK/PD) of Recombinant Human Coagulation Factor VIIa for Injection in Patients With Hemophilia.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Aim of this trial is to assess the pharmacokinetics and pharmacodynamics (PK/PD) of recombinant human coagulation factor VIIa for injection (FⅦa) in patients with hemophilia.

Conditions

• Hemophilia A With Inhibitor
• Hemophilia B With Inhibitor

Interventions

Type	Name	Description
DRUG	TQG203	TQG203,30µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.
DRUG	TQG203/NovoSeven®	In each of the two study periods (separated by a washout about two days),a single dose of TQG203 or NovoSeven® will be administered.TQG203 or NovoSeven®,90µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1.
DRUG	TQG203	TQG203,180µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2021-02-24
• Last updated: 2021-02-24

Locations

1 site across 1 country: China