Open-Label, Non-controlled, Single Ascending Dose Study to Evaluate Safety,Tolerability, Pharmacokinetics, and Exploratory Efficacy of KTP-001 in Subjects with Lumbar Disc Herniation

Trial ID:
IRB-13-6240
Timothy Peppers
The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in subjects with lumbar disc herniation.

Inclusion Criteria:

  • Subject has had a single contained or noncontained (extruded) lumbar disc herniation (L3-L4, L4-L5 or L5-S1) diagnosed by clinical symptoms and/or physical findings and confirmed by MRI.
  • Subject has leg pain with a documented positive straight leg raise (SLR) test or femoral stretch test (FST).
  • Subject has experiences herniated disc symptoms for at least 6 weeks prior to the study without relief with pain medications and other therapies.
  • Subject has a BMI of 18 to 35 kg/m2

Exclusion Criteria:

  • Subject has a sequestered lumbar disc herniation or intrathecal herniation confirmed by MRI
  • Subject has two or more symptomatic lumbar disc herniations
  • Previous intradiscal therapeutic intervention or has had any lumbar surgery
  • Presence of lumbar spine disease and/or deformity other than a lumbar disc herniation
  • Active smoker or is unable to abstain from tobacco use for 2 weeks prior to study injection
  • Subject has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease

Contact Info:

  • Michael Beblavy
  • michael.beblavy@iconplc.com
  • 215-616-3243