drugset / Trial / NCT05651061

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

NCT05651061 ↗

Phase 1 Completed 27 enrolled Hangzhou Gensciences Biopharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-12-14
Primary completion
2023-03-31
Completion
2023-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject SS109 Unknown 30 ug/kg Other
Subject SS109 Unknown 360 ug/kg Other