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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005224-15 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose (SAD): BG00010 | Experimental | Up to five cohorts of healthy volunteers will receive a single dose of intravenous (IV) BG00010 followed by a single SC dose of BG00010 2 weeks apart. |
|
| SAD: Placebo | Experimental | Up to five cohorts of healthy volunteers will receive a single IV dose of placebo followed by a single SC dose of placebo 2 weeks apart. |
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| Multiple Ascending Dose (MAD): BG00010 | Experimental | Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of BG00010. |
|
| Multiple Ascending Dose (MAD): Placebo | Experimental | Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG00010 IV | Biological | Ascending Doses intravenous (IV) of BG00010 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs) | Up to Day 75 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) of BG00010 | Pre-dose and up to 24 hours post-dose | |
| Time to maximum serum concentration (Tmax) of BG00010 | Pre-dose and up to 24 hours post-dose | |
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Key Inclusion Criteria: Part I and Part II
Key Inclusion Criteria: Part III multiple ascending dose (MAD)
Key Inclusion Criteria for All Subjects for Part I, Part II, Part III:
Key Exclusion Criteria for All Subjects for Part I, Part II, Part III:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Human Drug Research | Leiden | Netherlands |
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| ID | Term |
|---|---|
| D012585 | Sciatica |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D020932 | Nerve Growth Factor |
| ID | Term |
|---|---|
| D009414 | Nerve Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| BG00010 SC | Biological | Ascending Doses subcutaneous (SC) of BG00010 |
|
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| Placebo IV | Drug | Ascending Doses intravenous (IV) of Placebo |
|
| Placebo SC | Drug | Ascending Doses subcutaneous (SC) of placebo |
|
| Half life (t1/2) of BG00010 |
| Pre-dose and up to 24 hours post-dose |
| Area under the serum concentration time curve (AUC) from zero to infinity AUC(0-∞) for BG00010 | Pre-dose and up to 24 hours post-dose |
| Subcutaneous (SC) bioavailability | Pre-dose and up to 24 hours post-dose |
| Number of participants with anti-BG00010 antibodies in serum | Up to Day 75 |
| Pain as measured by an 11-point numeric rating scale (NRS) | The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). | Up to Day 75 |
| Pain as measured by short form McGill pain questionnaire (SF-MPQ) visual analog scale (VAS) | A 10 cm visual analog scale ranging from 0 (no pain) to 10 (worst possible pain). | Up to Day 75 |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011506 | Proteins |
| D009419 | Nerve Tissue Proteins |
| D001685 | Biological Factors |