A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102

Overview

This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.

Full Title of Study: “An Open-label, Single-arm Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102 Administered by Epidural Injection in Subjects With Lumbosacral Radiculopathy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 15, 2019

Interventions

  • Drug: SP-102
    • Injection

Arms, Groups and Cohorts

  • Experimental: SP-102
    • SP-102

Clinical Trial Outcome Measures

Primary Measures

  • Change in plasma cortisol in mcg/dL
    • Time Frame: Baseline, 12 Weeks
  • Change of white blood cell counts in 10^3/mcL
    • Time Frame: Baseline, 12 Weeks
  • Change in blood glucose in mg/dL
    • Time Frame: Baseline, 12 Weeks

Participating in This Clinical Trial

Main Inclusion Criteria:

  • Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures.
  • Age 18 to 70 years (inclusive) at the Screening Visit.
  • A diagnosis of lumbosacral radicular pain (sciatica).
  • Agrees to follow study-specific medication requirements.
  • If sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study.
  • Has reviewed all study specific materials and has, in the opinion of the Investigator, the abilities to understand and appropriately complete all study procedures.

Main Exclusion Criteria:

  • Has radiologic evidence of a condition that would compromise study outcomes.
  • Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study.
  • Has been diagnosed with insulin dependent diabetes mellitus.
  • Presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the Investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
  • Use of any investigational drug and/or device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study.
  • Has a body mass index ≥40 kg/m2.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Semnur Pharmaceuticals, Inc.
  • Collaborator
    • Worldwide Clinical Trials
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dmitri Lissin, MD, Study Director, Semnur Pharmaceuticals, Inc.

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