A Multiple Dose Safety Study of PEG-IFN in Healthy Volunteers

Phase 1 Completed 69 enrolled Biogen

RandomizedSingle-groupDouble-blindTreatment

Summary

The primary objectives are to identify the highest safe and well-tolerated dose and frequency of BIIB017 (PEGylated Interferon Beta-1a) subcutaneous (SC), within the range of 63 to 188 mcg, when given every other week or every 4 weeks to healthy volunteers (HV).

Timeline

Start: 2008-03
Primary completion: 2008-05
Completion: 2008-05

Publications

Results Hu X, Miller L, Richman S, Hitchman S, Glick G, Liu S, Zhu Y, Crossman M, Nestorov I, Gronke RS, Baker DP, Rogge M, Subramanyam M, Davar G. A novel PEGylated interferon beta-1a for multiple sclerosis: safety, pharmacology, and biology. J Clin Pharmacol. 2012 Jun;52(6):798-808. doi: 10.1177/0091270011407068. Epub 2011 Jun 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	peginterferon beta-1a	Protein / enzyme biologic	—	Subcutaneous

Indications

No indication recorded.