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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Painful Lumbar Radiculopathy; Healthy	Biological: BG00010 IV; Biological: BG00010 SC; Drug: Placebo IV; Drug: Placebo SC	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	54 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	April 2013
Actual Primary Completion Date :	August 2014
Actual Study Completion Date :	August 2014

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 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.	Biological: BG00010 IV; Ascending Doses intravenous (IV) of BG00010; Other Name: Neublastin Biological: BG00010 SC; Ascending Doses subcutaneous (SC) of BG00010; Other Name: Neublastin
Experimental: 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.	Drug: Placebo IV; Ascending Doses intravenous (IV) of Placebo Drug: Placebo SC; Ascending Doses subcutaneous (SC) of placebo
Experimental: Multiple Ascending Dose (MAD): BG00010; Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of BG00010.	Biological: BG00010 SC; Ascending Doses subcutaneous (SC) of BG00010; Other Name: Neublastin
Experimental: Multiple Ascending Dose (MAD): Placebo; Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of placebo.	Drug: Placebo SC; Ascending Doses subcutaneous (SC) of placebo

Outcome Measures

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Primary Outcome Measures :

1. The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs) [ Time Frame: Up to Day 75 ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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Locations

Netherlands
Center for Human Drug Research
Leiden, Netherlands

Sponsors and Collaborators

Biogen

Investigators

Study Director:	Medical Director	Biogen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Biogen
ClinicalTrials.gov Identifier:	NCT01842126 History of Changes
Other Study ID Numbers:	103NS103; 2012-005224-15 ( EudraCT Number )
First Posted:	April 29, 2013
Last Update Posted:	February 9, 2015
Last Verified:	February 2015

Keywords provided by Biogen:

Sciatica

Additional relevant MeSH terms:

Pain; Radiculopathy; Neurologic Manifestations; Nervous System Diseases	Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases