drugset / Trial / NCT04578535
A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants
Phase 1
Completed
51 enrolled
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire · collab
RandomizedParallel-groupOpen-labelBasic science
Summary
The purpose of the study is to assess the tolerability, safety, and pharmacokinetics of HYQVIA with ramp-up and no ramp-up dosing in healthy adult participants.
Timeline
- Start
- 2020-10-27
- Primary completion
- 2022-03-02
- Completion
- 2022-03-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HYQVIA | Protein / enzyme biologic | 0.4 g/kg | Subcutaneous |
| Subject | HYQVIA | Protein / enzyme biologic | 1 g/kg | Subcutaneous |
Indications
No indication recorded.