Clinical trial NCT01842126: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Painful Lumbar Radiculopathy
Healthy
Keywords: Sciatica
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2013-04-29
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)
timeFrame: Up to Day 75
Secondary outcomes:
measure: Maximum observed concentration (Cmax) of BG00010
timeFrame: Pre-dose and up to 24 hours post-dose
measure: Time to maximum serum concentration (Tmax) of BG00010
timeFrame: Pre-dose and up to 24 hours post-dose
measure: Half life (t1/2) of BG00010
timeFrame: Pre-dose and up to 24 hours post-dose
measure: Area under the serum concentration time curve (AUC) from zero to infinity AUC(0-∞) for BG00010
timeFrame: Pre-dose and up to 24 hours post-dose
measure: Subcutaneous (SC) bioavailability
timeFrame: Pre-dose and up to 24 hours post-dose
measure: Number of participants with anti-BG00010 antibodies in serum
timeFrame: Up to Day 75
measure: Pain as measured by an 11-point numeric rating scale (NRS)
timeFrame: Up to Day 75
measure: Pain as measured by short form McGill pain questionnaire (SF-MPQ) visual analog scale (VAS)
timeFrame: Up to Day 75
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Center for Human Drug Research
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: