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

Semnur Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Lumbosacral Radicular Pain

Treatments

Drug: SP-102

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03613662

SP-102-03

Details and patient eligibility

About

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

Enrollment

19 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.