Status:
COMPLETED
Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)
Lead Sponsor:
Biogen
Conditions:
Painful Lumbar Radiculopathy
Healthy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 multipl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01842126
Start Date
April 1 2013
End Date
August 1 2014
Last Update
February 9 2015
Active Locations (1)
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1
Center for Human Drug Research
Leiden, Netherlands