Back to resultsPhase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)
Primary Purpose
Painful Lumbar Radiculopathy, Healthy
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
BG00010 IV
BG00010 SC
Placebo IV
Placebo SC
Sponsored by
About this trial
This is an interventional treatment trial for Painful Lumbar Radiculopathy focused on measuring Sciatica
Eligibility Criteria
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.
Sites / Locations
- Center for Human Drug Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Single Ascending Dose (SAD): BG00010
SAD: Placebo
Multiple Ascending Dose (MAD): BG00010
Multiple Ascending Dose (MAD): Placebo
Arm Description
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.
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.
Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of BG00010.
Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of placebo.
Outcomes
Primary Outcome Measures
The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)
Secondary Outcome Measures
Maximum observed concentration (Cmax) of BG00010
Time to maximum serum concentration (Tmax) of BG00010
Half life (t1/2) of BG00010
Area under the serum concentration time curve (AUC) from zero to infinity AUC(0-∞) for BG00010
Subcutaneous (SC) bioavailability
Number of participants with anti-BG00010 antibodies in serum
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01842126
Brief Title
Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Lumbar Radiculopathy, Healthy
Keywords
Sciatica
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Ascending Dose (SAD): BG00010
Arm Type
Experimental
Arm Description
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.
Arm Title
SAD: Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Multiple Ascending Dose (MAD): BG00010
Arm Type
Experimental
Arm Description
Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of BG00010.
Arm Title
Multiple Ascending Dose (MAD): Placebo
Arm Type
Experimental
Arm Description
Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of placebo.
Intervention Type
Biological
Intervention Name(s)
BG00010 IV
Other Intervention Name(s)
Neublastin
Intervention Description
Ascending Doses intravenous (IV) of BG00010
Intervention Type
Biological
Intervention Name(s)
BG00010 SC
Other Intervention Name(s)
Neublastin
Intervention Description
Ascending Doses subcutaneous (SC) of BG00010
Intervention Type
Drug
Intervention Name(s)
Placebo IV
Intervention Description
Ascending Doses intravenous (IV) of Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo SC
Intervention Description
Ascending Doses subcutaneous (SC) of placebo
Primary Outcome Measure Information:
Title
The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)
Time Frame
Up to Day 75
Secondary Outcome Measure Information:
Title
Maximum observed concentration (Cmax) of BG00010
Time Frame
Pre-dose and up to 24 hours post-dose
Title
Time to maximum serum concentration (Tmax) of BG00010
Time Frame
Pre-dose and up to 24 hours post-dose
Title
Half life (t1/2) of BG00010
Time Frame
Pre-dose and up to 24 hours post-dose
Title
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
Title
Subcutaneous (SC) bioavailability
Time Frame
Pre-dose and up to 24 hours post-dose
Title
Number of participants with anti-BG00010 antibodies in serum
Time Frame
Up to Day 75
Title
Pain as measured by an 11-point numeric rating scale (NRS)
Description
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).
Time Frame
Up to Day 75
Title
Pain as measured by short form McGill pain questionnaire (SF-MPQ) visual analog scale (VAS)
Description
A 10 cm visual analog scale ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame
Up to Day 75
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Center for Human Drug Research
City
Leiden
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)
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