PK/PD Study of 2 Agalsidase Formulations in Single Dose of 1 mg/kg Administered to Healthy Volunteers as IV Infusion

Phase 1 Completed 24 enrolled Bio Sidus SA

RandomizedParallel-groupSingle-blindTreatment

Summary

Pharmacokinetic/Pharmacodynamic Study of 2 agalsidase beta Formulations in Single Dose Administered to Healthy Volunteers as intravenous infusion, at a concentration of 1 mg/kg

Timeline

Start: 2021-10-23
Primary completion: 2022-03-06
Completion: 2022-04-17

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	agalsidase beta	Protein / enzyme biologic	1 mg/kg	Intravenous

PK/PD Study of 2 Agalsidase Formulations in Single Dose of 1 mg/kg Administered to Healthy Volunteers as IV Infusion

Summary

Timeline

Drugs

Indications