NCT05651061

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Jiangsu Gensciences lnc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hemophilia A With Inhibitor
• Hemophilia B With Inhibitor
• Factor VII Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	SS109	27 patients are enrolled in cohorts ,and will continue to be followed up until 28 days after SS109 administration for evaluating safety, PK/PD and immunogenicity.

Timeline

• Start date: 2022-12-14
• Primary completion: 2023-03-31
• Completion: 2023-08-15
• First posted: 2022-12-14
• Last updated: 2023-08-22

Locations

10 sites across 1 country: China