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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842126
• Other study ID #: 103NS103
• Secondary ID: 2012-005224-15
• Status: Completed
• Phase: Phase 1
• First received: April 25, 2013
• Last updated: February 5, 2015
• Start date: April 2013
• Est. completion date: August 2014

Study information

• Verified date: February 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy
• Painful Lumbar Radiculopathy
• Radiculopathy

Intervention

Biological:
• BG00010 IV
Ascending Doses intravenous (IV) of BG00010
• BG00010 SC
Ascending Doses subcutaneous (SC) of BG00010

Drug:
• Placebo IV
Ascending Doses intravenous (IV) of Placebo
• Placebo SC
Ascending Doses subcutaneous (SC) of placebo

Locations

Country	Name	City	State
Netherlands	Center for Human Drug Research	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)		Up to Day 75	Yes
Secondary	Maximum observed concentration (Cmax) of BG00010		Pre-dose and up to 24 hours post-dose	No
Secondary	Time to maximum serum concentration (Tmax) of BG00010		Pre-dose and up to 24 hours post-dose	No
Secondary	Half life (t1/2) of BG00010		Pre-dose and up to 24 hours post-dose	No
Secondary	Area under the serum concentration time curve (AUC) from zero to infinity AUC(0-8) for BG00010		Pre-dose and up to 24 hours post-dose	No
Secondary	Subcutaneous (SC) bioavailability		Pre-dose and up to 24 hours post-dose	No
Secondary	Number of participants with anti-BG00010 antibodies in serum		Up to Day 75	No
Secondary	Pain as measured by an 11-point numeric rating scale (NRS)	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).	Up to Day 75	No
Secondary	Pain as measured by short form McGill pain questionnaire (SF-MPQ) visual analog scale (VAS)	A 10 cm visual analog scale ranging from 0 (no pain) to 10 (worst possible pain).	Up to Day 75	No