A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants

Summary

This study is for healthy participants. This study tests single dose of the research drug HSP-130 against two existing approved drugs United States - approved Neulasta and European Union-approved Neulasta.

Timeline

Start

2015-08

Primary completion

2016-06

Completion

2016-06

Publications

• Moosavi S, Borema T, Ewesuedo R, Harris S, Levy J, May TB, Summers M, Thomas JS, Zhang J, Yao HM. PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta(R)): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers. Adv Ther. 2020 Jul;37(7):3370-3391. doi: 10.1007/s12325-020-01387-x. Epub 2020 Jun 10.

Drugs

Indications