drugset / Trial / NCT03408132

Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency

NCT03408132 ↗

Phase 1/2 Completed 8 enrolled GlyPharma Therapeutics VectivBio AG · collab
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

EvaluationDrugModalityDoseRoute
Subject FE203799 Protein / enzyme biologic 5 mg Subcutaneous

Indications