Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)
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ClinicalTrials.gov Identifier: NCT01842126 |
Recruitment Status
:
Completed
First Posted
: April 29, 2013
Last Update Posted
: February 9, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Painful Lumbar Radiculopathy Healthy | Biological: BG00010 IV Biological: BG00010 SC Drug: Placebo IV Drug: Placebo SC | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | August 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Single Ascending Dose (SAD): BG00010
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.
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Biological: BG00010 IV
Ascending Doses intravenous (IV) of BG00010
Other Name: Neublastin
Biological: BG00010 SC
Ascending Doses subcutaneous (SC) of BG00010
Other Name: Neublastin
|
Experimental: SAD: Placebo
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.
|
Drug: Placebo IV
Ascending Doses intravenous (IV) of Placebo
Drug: Placebo SC
Ascending Doses subcutaneous (SC) of placebo
|
Experimental: Multiple Ascending Dose (MAD): BG00010
Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of BG00010.
|
Biological: BG00010 SC
Ascending Doses subcutaneous (SC) of BG00010
Other Name: Neublastin
|
Experimental: Multiple Ascending Dose (MAD): Placebo
Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of placebo.
|
Drug: Placebo SC
Ascending Doses subcutaneous (SC) of placebo
|
- The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs) [ Time Frame: Up to Day 75 ]
- Maximum observed concentration (Cmax) of BG00010 [ Time Frame: Pre-dose and up to 24 hours post-dose ]
- Time to maximum serum concentration (Tmax) of BG00010 [ Time Frame: Pre-dose and up to 24 hours post-dose ]
- Half life (t1/2) of BG00010 [ Time Frame: 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 [ Time Frame: Pre-dose and up to 24 hours post-dose ]
- Subcutaneous (SC) bioavailability [ Time Frame: Pre-dose and up to 24 hours post-dose ]
- Number of participants with anti-BG00010 antibodies in serum [ Time Frame: Up to Day 75 ]
- Pain as measured by an 11-point numeric rating scale (NRS) [ Time Frame: Up to Day 75 ]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).
- Pain as measured by short form McGill pain questionnaire (SF-MPQ) visual analog scale (VAS) [ Time Frame: Up to Day 75 ]A 10 cm visual analog scale ranging from 0 (no pain) to 10 (worst possible pain).

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Key Inclusion Criteria: Part I and Part II
- Healthy Volunteers
Key Inclusion Criteria: Part III multiple ascending dose (MAD)
- Subjects must have a diagnosis of unilateral painful lumbar radiculopathy and painful lumbar radiculopathy symptoms must be present for 3 or more months prior to the Screening Visit.
- Subjects must rate their pain at ≥40 mm on the 100 mm visual analog scale (VAS) of the short form McGill pain questionnaire (SF-MPQ) at the Screening and Baseline Visits.
Key Inclusion Criteria for All Subjects for Part I, Part II, Part III:
- All male subjects and all female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment. -
Key Exclusion Criteria for All Subjects for Part I, Part II, Part III:
- History of or positive screening test for hepatitis C infection , hepatitis B infection, or positive for human immunodeficiency virus (HIV) antibody. Subjects who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive are allowed to participate if they are positive for HBsAb immunoglobulin G
- History of malignancy or clinically relevant (as determined by the Investigator) allergies; cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to painful lumbar radiculopathy), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
- Relevant history of illicit drug or alcohol abuse (as defined by the Investigator) within 1 year prior to the Screening Visit. -
- Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at the Screening or Baseline Visits.
- Previous administration of a neurotrophic factor, including BG00010.
- Participation in a study with another investigational drug or approved therapy for investigational use within the 3 months prior to the Baseline Visit, or current enrollment in any other study.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842126
Netherlands | |
Center for Human Drug Research | |
Leiden, Netherlands |
Study Director: | Medical Director | Biogen |
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT01842126 History of Changes |
Other Study ID Numbers: |
103NS103 2012-005224-15 ( EudraCT Number ) |
First Posted: | April 29, 2013 Key Record Dates |
Last Update Posted: | February 9, 2015 |
Last Verified: | February 2015 |
Keywords provided by Biogen:
Sciatica |
Additional relevant MeSH terms:
Pain Radiculopathy Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Peripheral Nervous System Diseases Neuromuscular Diseases |