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Completed

NCT Number: NCT01842126

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

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.

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Key information

Conditions

Painful Lumbar Radiculopathy Healthy Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Sciatica Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Center for Human Drug Research

Leiden, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BG00010 IV

Biological

Ascending Doses intravenous (IV) of BG00010

Other names: Neublastin

BG00010 SC

Biological

Ascending Doses subcutaneous (SC) of BG00010

Other names: Neublastin

Placebo IV

Drug

Ascending Doses intravenous (IV) of Placebo

Placebo SC

Drug

Ascending Doses subcutaneous (SC) of placebo

Primary outcomes

  1. The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)

    Time frame: Up to Day 75

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 29, 2013
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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