drugset / Trial / NCT05418829
AT-007 in Adult Subjects With Classic Galactosemia (CG)
NaSingle-groupOpen-labelTreatment
Summary
This study is a 12-month open-label extension (OLE) study of AT-007 in adult subjects with CG who previously participated in Study AT-007-1001 Part D and/or Part D Extension. The study is designed to assess the long-term safety of AT-007 in subjects with CG as well as the pharmacodynamics (PD) (inhibition of galactitol) and PK of AT-007. The effect of 12-month treatment with AT-007 on the levels of galactose and other galactose metabolites in subjects with CG will also be evaluated.
Timeline
- Start
- 2021-10-01
- Primary completion
- 2022-11
- Completion
- 2022-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Govorestat | Small molecule | 20 mg/kg | Oral |