Available IPD datapackage for study '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'

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.