NCT01842126

Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)

Study of Safety, Tolerability, and Pharmacokinetics of BG00010 (Neublastin) Intravenous and Subcutaneous Single Ascending Doses in Healthy Volunteers, and Subcutaneous Multiple Ascending Doses in Subjects With Painful Lumbar Radiculopathy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to evaluate the safety and tolerability of a range of single intravenous (IV) and subcutaneous (SC) doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in participants with painful lumbar radiculopathy. Secondary objectives of this study are to determine the single IV and SC dose pharmacokinetics (PK) profile of BG00010 in healthy volunteers including assessment of bioavailability by comparing SC exposure to IV exposure in each participant, to determine the multiple SC dose PK profiles of BG00010 in participants with painful lumbar radiculopathy, to assess the single IV and SC dose immunogenicity of BG00010 in healthy volunteers, to assess the multiple SC dose immunogenicity of BG00010 in participants with painful lumbar radiculopathy, and to assess the potential of BG00010 to reduce pain following multiple SC administrations in participants with painful lumbar radiculopathy.

Conditions

• Painful Lumbar Radiculopathy
• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	BG00010 IV	Ascending Doses intravenous (IV) of BG00010
BIOLOGICAL	BG00010 SC	Ascending Doses subcutaneous (SC) of BG00010
DRUG	Placebo IV	Ascending Doses intravenous (IV) of Placebo
DRUG	Placebo SC	Ascending Doses subcutaneous (SC) of placebo

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-04-29
• Last updated: 2015-02-09

Locations

1 site across 1 country: Netherlands