drugset / Trial / NCT05651061
A Phase I of SS109 in Hemophilia A or and B With Inhibitors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SS109 | Unknown | 30 ug/kg | Other |
| Subject | SS109 | Unknown | 360 ug/kg | Other |