Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to determine the safety/tolerability profile, systemic PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica participants.

Official Title
-----------------
Phase 1: A Single-Center, Randomized, Blinded, Placebo-Controlled, Single-Administration, Sequential-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants

Conditions
-----------------
Sciatica

Intervention / Treatment
-----------------
* Drug: BG00010 (Neublastin)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Must have a diagnosis of unilateral sciatica, determined by the Investigator. Sciatica symptoms must be present for 6 or more weeks prior to the Screening Visit. Must have a body mass index (BMI) between 18 kg/m2 and 32 kg/m2. 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 Exclusion Criteria: History of malignancy or clinically significant (as determined by the Investigator) allergies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to sciatica), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease. History of signs or symptoms of peripheral neuropathy, other than symptoms of sciatica. History of severe allergic or anaphylactic drug-related reactions. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BG00010 (Neublastin)<br>Participants may be randomized to escalating doses of BG00010 or matching placebo | Drug: BG00010 (Neublastin)<br>* Single dose, weight-based IV administration<br>|
| Placebo Comparator: Placebo<br>Participants may be randomized to escalating doses of BG00010 or matching placebo | Drug: Placebo<br>* Single dose IV matched placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants experiencing Adverse Events (AEs) |  | Up to 56 days post dosing | 
| Change in Likert numerical pain rating scale |  | Up to 56 days post dosing | 
| Change in Quantitative Sensory Test (QST) | QST; Vibratory, Cool Thermal, | Up to 28 days post dosing | 
| Change in Intra Epidermal Nerve Fiber Density (IENFD) |  | Up to 28 days post dosing | 
| Maximum observed serum concentration (Cmax) |  | Up to 5 days post dosing | 
| Area under the serum concentration curve (AUC) |  | Up to 5 days post dosing | 
| Terminal half-life (t1/2) |  | Up to 5 days post dosing | 
| Total body clearance (CL) |  | Up to 5 days post dosing | 
| Steady state volume of distribution (Vss) |  | Up to 5 days post dosing |