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

Phase 1

Completed

• Conditions: Healthy; Painful Lumbar Radiculopathy
• Interventions: Drug: Placebo IV; Biological: BG00010 SC; Biological: BG00010 IV; Drug: Placebo SC

• Registration Number: NCT01842126
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-25
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-29
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-05
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAD: Placebo	Placebo SC	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.
SAD: Placebo	Placebo IV	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.
Multiple Ascending Dose (MAD): BG00010	BG00010 SC	Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of BG00010.
Single Ascending Dose (SAD): BG00010	BG00010 IV	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.
Single Ascending Dose (SAD): BG00010	BG00010 SC	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.
Multiple Ascending Dose (MAD): Placebo	Placebo SC	Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of placebo.

Primary Outcome Measures

Name	Time	Method
The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)	Up to Day 75

Secondary Outcome Measures

Name	Time	Method
Time to maximum serum concentration (Tmax) of BG00010	Pre-dose and up to 24 hours post-dose
Area under the serum concentration time curve (AUC) from zero to infinity AUC(0-∞) for BG00010	Pre-dose and up to 24 hours post-dose
Half life (t1/2) of BG00010	Pre-dose and up to 24 hours post-dose
Number of participants with anti-BG00010 antibodies in serum	Up to Day 75
Subcutaneous (SC) bioavailability	Pre-dose and up to 24 hours post-dose
Pain as measured by short form McGill pain questionnaire (SF-MPQ) visual analog scale (VAS)	Up to Day 75	A 10 cm visual analog scale ranging from 0 (no pain) to 10 (worst possible pain).
Maximum observed concentration (Cmax) of BG00010	Pre-dose and up to 24 hours post-dose
Pain as measured by an 11-point numeric rating scale (NRS)	Up to Day 75	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).

Trial Locations

Locations (1)

Center for Human Drug Research; 🇳🇱 Leiden, Netherlands