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A Phase I of SS109 in Hemophilia A or and B With Inhibitors

Hemophilia A With Inhibitor Clinical Trial

Official title:
To Evaluate the Safety, PK/PD and Immunogenicity of SS109 in Hemophilia Patients With Blood Coagulation Factor Ⅷ or Ⅸ Inhibitors After Single Administration, Open Label, Dose Escalation, and Multicenter Phase I Clinical Trial

Clinical Trial Summary

This phase I study aims to evaluate the safety, PK/PD and immunogenicity of SS109 in hemophilia A or and B with inhibitors. Twenty -seven patients are enrolled in study, and divided into five dose cohorts, from 30μg/kg to 360μg/kg. Dose 1 cohort enrolls three patients, each other dose cohorts enroll six patients. All patients included in the study will continue to be followed up until 28 days after SS109 administration.

Clinical Trial Description

This study is an open label, dose escalation, multicenter clinical trial. The study sets up a science review committee to assess the dose escalation. Serial blood samples for PK/PD analysis will be taken up to 72 hours after SS109 injection. Patients safety will be routinely monitored throughout the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05651061
Study type Interventional
Source Jiangsu Gensciences lnc.
Contact
Status Completed
Phase Phase 1
Start date December 14, 2022
Completion date August 15, 2023
View Details
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