Safety, Pharmacokinetic, Immunogenicity, and Pharmacodynamic Responses in Healthy Volunteers Following a Single Intravenous Injection of Purified Staphylococcal Protein A
Article first published online: 7 JUL 2013
© 2013, The American College of Clinical Pharmacology
The Journal of Clinical Pharmacology
Volume 53, Issue 9, pages 909–918, September 2013
How to Cite
Ballow, C., Leh, A., Slentz-Kesler, K., Yan, J., Haughey, D. and Bernton, E. (2013), Safety, Pharmacokinetic, Immunogenicity, and Pharmacodynamic Responses in Healthy Volunteers Following a Single Intravenous Injection of Purified Staphylococcal Protein A. Journal of Clinical Pharma, 53: 909–918. doi: 10.1002/jcph.119
- Issue published online: 5 AUG 2013
- Article first published online: 7 JUL 2013
- Manuscript Accepted: 6 MAY 2013
- Manuscript Received: 11 MAR 2013
Additional supporting information may be found in the online version of this article at the publisher's web-site.
Figure S1. Graphic displays of AUC versus percentage change in ALC at 24 hours after SPA dosing shows no correlation.
Table S1. Summary of Treatment-Emergent (TEAEs) and Treatment-Related Adverse Events (TRAEs)
Table S2. Plasma SPA Clearance and Distribution Parameters by Dose and Ultimate Anti-Product Antibody Status
Table S3. Changes in PFA-100 Closure Times After SPA Dosing in Study B
Table S4. Serum Cmax and AUC Values With Corresponding Percent Change in ALC at 24 hours After Dosing
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