drugset
drugset / Trial / NCT05396742

Pharmacokinetic Study of Ravulizumab Administered Subcutaneously With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers

NCT05396742 ↗

Phase 1 Completed 49 enrolled Alexion Pharmaceuticals, Inc.
RandomizedParallel-groupOpen-labelBasic science

Summary

The main objectives of this study were to estimate the absolute bioavailability of ravulizumab/rHuPH20 subcutaneous (SC) and to assess the safety and tolerability of ravulizumab/rHuPH20 SC.

Timeline

Start
2018-08-09
Primary completion
2019-05-21
Completion
2019-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Ravulizumab Monoclonal antibody 400 mg Subcutaneous
Subject Ravulizumab Monoclonal antibody 500 mg Subcutaneous
Subject Ravulizumab Monoclonal antibody 1000 mg Subcutaneous
Subject Ravulizumab Monoclonal antibody 2000 mg Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 10000 iu Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 20000 iu Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 40000 iu Subcutaneous

Indications

No indication recorded.