drugset / Trial / NCT03408132
Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency
NaSingle-groupOpen-labelSupportive care
Summary
This is a repeated dose, open label trial investigating safety, efficacy, PD and PK of FE 203799 in 8 patients with SBS. The patients will receive a subcutaneous (SC) dose of 5 mg FE 203799 once weekly for 4 consecutive weeks, and efficacy parameters and PK will be assessed after the fourth dose. Safety follow up assessments will be performed 4-6 weeks after the last dose.
Timeline
- Start
- 2018-05-02
- Primary completion
- 2019-10-28
- Completion
- 2019-10-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FE203799 | Protein / enzyme biologic | 5 mg | Subcutaneous |