drugset / Trial / NCT01426763
A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase
Non-randomizedParallel-groupOpen-labelOther
Summary
The objectives of the study are to: 1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE) who previously participated in CINRYZE Study 0624-200 (NCT01095497) 2. Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered CINRYZE with rHuPH20 3. Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of CINRYZE with rHuPH20
Timeline
- Start
- 2011-09-12
- Primary completion
- 2011-11-28
- Completion
- 2011-11-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CINRYZE | Protein / enzyme biologic | 1000 iu | Subcutaneous |
| Subject | CINRYZE | Protein / enzyme biologic | 2000 iu | Subcutaneous |
| Subject | rHuPH20 | Protein / enzyme biologic | 20000 iu | Subcutaneous |
| Subject | rHuPH20 | Protein / enzyme biologic | 40000 iu | Subcutaneous |