Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants

Phase 1 Completed 48 enrolled Biogen

RandomizedParallel-groupSingle-blindTreatment

Summary

The primary objective of the study is to determine the safety/tolerability profile, systemic PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica participants.

Timeline

Start: 2009-08
Primary completion: 2012-02
Completion: 2012-02

Publications

Rolan PE, O'Neill G, Versage E, Rana J, Tang Y, Galluppi G, Aycardi E. First-In-Human, Double-Blind, Placebo-Controlled, Randomized, Dose-Escalation Study of BG00010, a Glial Cell Line-Derived Neurotrophic Factor Family Member, in Subjects with Unilateral Sciatica. PLoS One. 2015 May 11;10(5):e0125034. doi: 10.1371/journal.pone.0125034. eCollection 2015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	artemin	Protein / enzyme biologic	0.3 ug/kg	Intravenous
Subject	artemin	Protein / enzyme biologic	1 ug/kg	Intravenous
Subject	artemin	Protein / enzyme biologic	3 ug/kg	Intravenous
Subject	artemin	Protein / enzyme biologic	10 ug/kg	Intravenous
Subject	artemin	Protein / enzyme biologic	25 ug/kg	Intravenous
Subject	artemin	Protein / enzyme biologic	50 ug/kg	Intravenous
Subject	artemin	Protein / enzyme biologic	100 ug/kg	Intravenous
Subject	artemin	Protein / enzyme biologic	200 ug/kg	Intravenous
Subject	artemin	Protein / enzyme biologic	400 ug/kg	Intravenous
Subject	artemin	Protein / enzyme biologic	800 ug/kg	Intravenous

Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants

Summary

Timeline

Publications

Drugs

Indications