Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01842126
First received: April 25, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

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 subcutaneous (SC) doses of BG00010 in subjects 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 subcutaneous (SC) exposure to IV exposure in each subject.
  • To determine the multiple subcutaneous (SC) dose PK profiles of BG00010 in subjects with painful lumbar radiculopathy.
  • To assess the single IV and subcutaneous (SC) dose immunogenicity of BG00010 in healthy volunteers.
  • To assess the multiple SC dose immunogenicity of BG00010 in subjects with painful lumbar radiculopathy.
  • To assess the potential of BG00010 to reduce pain following multiple SC administrations in subjects with painful lumbar radiculopathy.

Condition Intervention Phase
Painful Lumbar Radiculopathy
Healthy
Biological: BG00010
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • The incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs) [ Time Frame: Up to Day 75 for each group/arm ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum observed concentration (Cmax) [ Time Frame: Up to Day 75 ] [ Designated as safety issue: No ]
  • Time to maximum serum concentration (Tmax) [ Time Frame: Up to Day 29 ] [ Designated as safety issue: No ]
  • Half life (t1/2) [ Time Frame: Up to Day 29 ] [ Designated as safety issue: No ]
  • Area under the serum concentration time curve (AUC) from zero to infinity AUC(0-∞) [ Time Frame: Up to Day 29 ] [ Designated as safety issue: No ]
  • Subcutaneous (SC) bioavailability [ Time Frame: Up to Day 29 ] [ Designated as safety issue: No ]
  • Incidence of anti-BG00010 antibodies in serum [ Time Frame: Up to Day 75 ] [ Designated as safety issue: No ]
  • Pain, as measured by an 11-point NRS, and by the VAS of SF-MPQ [ Time Frame: Up to Day 75 ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: April 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part I SAD
SAD: intravenous (IV) and subcutaneous (SC) doses of BG00010 or placebo in Healthy Volunteers
Biological: BG00010
Ascending Doses subcutaneous (SC) or intravenous (IV) of BG00010 (Part I SAD & Part II Extended SAD)
Other Name: Neublastin
Drug: Placebo
Ascending Doses subcutaneous (SC) or intravenous (IV) of Placebo (Part I SAD & Part II Extended SAD)
Experimental: Part II Extended SAD
Extended SAD: intravenous (IV) and subcutaneous (SC) doses of BG00010 or placebo in Healthy Volunteers
Biological: BG00010
Ascending Doses subcutaneous (SC) or intravenous (IV) of BG00010 (Part I SAD & Part II Extended SAD)
Other Name: Neublastin
Drug: Placebo
Ascending Doses subcutaneous (SC) or intravenous (IV) of Placebo (Part I SAD & Part II Extended SAD)
Experimental: Part III MAD
MAD: subcutaneous (SC) doses of BG00010 or placebo in subjects with painful lumbar radiculopathy
Biological: BG00010
Ascending Doses subcutaneous (SC) of BG00010 (Part III MAD & Part IV Extended MAD)
Other Name: Neublastin
Drug: Placebo
Ascending Doses subcutaneous (SC) of placebo (Part III MAD & Part IV Extended MAD)
Experimental: Part IV Extended MAD
Extended MAD: subcutaneous (SC) doses of BG00010 or placebo in subjects with painful lumbar radiculopathy
Biological: BG00010
Ascending Doses subcutaneous (SC) of BG00010 (Part III MAD & Part IV Extended MAD)
Other Name: Neublastin
Drug: Placebo
Ascending Doses subcutaneous (SC) of placebo (Part III MAD & Part IV Extended MAD)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Part I and Part II

  • Healthy Volunteers

Inclusion Criteria: Part III (MAD) and Part IV (Extended 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.

Inclusion Criteria for All Subjects for Part I, Part II, Part III, Part IV:

  • 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. -

Exclusion Criteria for All Subjects for Part I, Part II, Part III, Part IV:

  • History of or positive screening test for hepatitis C infection , hepatitis B infection, 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842126

Contacts
Contact: Biogen Idec neurologyclinicaltrials@biogenidec.com

Locations
Netherlands
Center for Human Drug Research Recruiting
Leiden, Netherlands
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01842126     History of Changes
Other Study ID Numbers: 103NS103
Study First Received: April 25, 2013
Last Updated: April 25, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Biogen Idec:
Sciatica

Additional relevant MeSH terms:
Pain
Radiculopathy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on August 27, 2014