Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)

NCT ID: NCT01842126

Last Updated: 2015-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-08-31

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.

Conditions

Painful Lumbar Radiculopathy; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single Ascending Dose (SAD): BG00010

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.

Group Type: EXPERIMENTAL

BG00010 IV

Intervention Type: BIOLOGICAL

Ascending Doses intravenous (IV) of BG00010

BG00010 SC

Intervention Type: BIOLOGICAL

Ascending Doses subcutaneous (SC) of BG00010

SAD: Placebo

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.

Group Type: EXPERIMENTAL

Placebo IV

Intervention Type: DRUG

Ascending Doses intravenous (IV) of Placebo

Placebo SC

Intervention Type: DRUG

Ascending Doses subcutaneous (SC) of placebo

Multiple Ascending Dose (MAD): BG00010

Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of BG00010.

Group Type: EXPERIMENTAL

BG00010 SC

Intervention Type: BIOLOGICAL

Ascending Doses subcutaneous (SC) of BG00010

Multiple Ascending Dose (MAD): Placebo

Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of placebo.

Group Type: EXPERIMENTAL

Placebo SC

Intervention Type: DRUG

Ascending Doses subcutaneous (SC) of placebo

Interventions

BG00010 IV

Ascending Doses intravenous (IV) of BG00010

Intervention Type: BIOLOGICAL

BG00010 SC

Ascending Doses subcutaneous (SC) of BG00010

Intervention Type: BIOLOGICAL

Placebo IV

Ascending Doses intravenous (IV) of Placebo

Intervention Type: DRUG

Placebo SC

Ascending Doses subcutaneous (SC) of placebo

Intervention Type: DRUG

Other Intervention Names

Neublastin; Neublastin

Eligibility Criteria

Inclusion Criteria

• Healthy Volunteers

• 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.

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Center for Human Drug Research

Leiden, , Netherlands

Countries

Netherlands

Other Identifiers

2012-005224-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

103NS103

Identifier Type: -

Identifier Source: org_study_id