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
- Conditions
- low back painPainful Lumbar Radiculopathy10041543
- Registration Number
- NL-OMON40320
- Lead Sponsor
- Biogen Idec
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 78
All subjects
-Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
-Must be 18 to 75 years old at the time of informed consent.
-Upper weight limits the number of SC injections per dose (maximum of 2 injections per dose.;Volunteers with Painful lumbar radiculopathy:
-Subjects must have a diagnosis of painful lumbar radiculopathy, determined by the Investigator, including pain radiating down the leg following a dermatome, suggesting L4, L5, or S1 nerve root involvement. 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 and more on the 100 mm VAS of the SF-MPQ at the Screening and Baseline Visits.
-All male 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.
All Subjects:
-History of or positive screening test for hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or positive for hepatitis B core antibody [HBcAb] at Screening), or positive for human immunodeficiency virus (HIV) antibody. Subjects who are HBsAg negative and HBcAb positive are allowed to participate if they are positive for HBsAb immunoglobulin G (see the Centers for Disease Control and Prevention's interpretation of the hepatitis B serology panel).
-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. Subjects must be willing to restrain from the use of illicit drug or consumption of alcoholic beverages within 24 hours prior to dosing on Day 1, and during the inpatient period.
-History of severe allergic or anaphylactic drug-related reactions.
-History of skin or systemic condition that predisposes to have pruritus, as determined by the Investigator.
-Clinically relevant abnormal electrocardiogram (12-lead ECG) at the Screening or Baseline Visits, as determined by the Investigator, or a marked prolongation of the QT corrected (QTc) interval (i.e., repeated demonstration of a QTc interval >450 msec for females or >430 msec for males) at the Screening or Baseline Visits.
-Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at the Screening or Baseline Visits.
-Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to the Baseline Visit.
-Any live or attenuated immunization/vaccination within 28 days prior to the Baseline Visit.
-Serum creatinine >1.5 x upper limit of normal (ULN).
-Treatment with any prescription medication and/or over the-counter products such as herbal supplements, unless the dose has been stable for 2 weeks prior to the Baseline Visit.
-Previous participation in a study with neurotrophic factors including BG00010.
-Smoke >5 cigarettes or the equivalent in tobacco per day. ;Subject with Painful lumbar radiculopathy:
-History of severe pain as judged by the Investigator, other than that caused by Painful lumbar radiculopathy, during the 3 months prior to the Screening Visit.
Signs or symptoms of peripheral neuropathy, other than symptoms of Painful lumbar radiculopathy, during the 3 months prior to the Screening Visit.
-Current generalized myalgia.
-Major or lumbar radiculopathy surgery within the 3 months prior to the Screening Visit or planned painful lumbar radiculopathy surgery within 3 months after the Screening Visit.
-Selective serotonin reuptake inhibitor (SSRI), serotonin noradrenaline reuptake inhibitor (SNRI), gabapentin, pregabalin, and tricyclic antidepressant (TCA) doses must be stable for 4 weeks prior to the Baseline Visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety:<br /><br>- AE and SAEs monitoring<br /><br>- clinical laboratory safety tests (hematology, clinical chemistry, and<br /><br>urinalysis)<br /><br>- physical and neurological examinations<br /><br>- vital signs<br /><br>- ECG<br /><br>- binding and neutralizing antibody assays.<br /><br>Pharmacokinetics Assessments:<br /><br>- BG00010 concentrations in serum<br /><br>Efficacy Assessments:<br /><br>- Numeric rating Scale<br /><br>- Visual Analogue Scale.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacodynamic (PD) Parameters:<br /><br>- Blood, serum, and plasma samples will be collected for analyses to identify<br /><br>potential biomarkers that may indicate BG00010 activity.</p><br>