Clareo Health | A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease
A Study of the Safety, Tolerability, and Pharmacokinetics of SM04690 Injectable Suspension Following Single Intradiscal Injection in Subjects With Degenerative Disc Disease
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Lead
Biosplice Therapeutics, Inc.
Age
25–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Degenerative disease in a maximum of two and a minimum of one lumbar disc (L4/L5 or L5/S1)
Persistent low back pain due to DDD for at least 3 months prior to study start
Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed
You may not be if
Women who are pregnant, lactating, or have a positive pregnancy result at study start
Women of child bearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period
Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized or whom are not using a highly effective method of birth control
Body mass index (BMI) \> 35
Previous participation in a Samumed clinical trial investigating SM04690
History of compression fractures and/or osteoporosis
Any herniation in the lumbar spine as identified by MRI
Congenital or acquired diseases leading to spine deformations
History of hypersensitivity or allergies to any ingredient of the study medication
Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure, or an observational research trial related to DDD within 8 weeks prior to any study injection, or planned participation in any such trial; the last date of participation in the trial, not the last date of receipt of investigational product, must be at least 8 weeks prior to study start
Poor peripheral venous access
Any contraindications to MRI according to MRI guidelines
History of malignancy; however, subjects with prior history of in situ cancer or basal or squamous cell skin cancer, completely cured, are eligible.
Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, schizoaffective disorder, major depressive disorder, or generalized anxiety disorder
Prior surgical procedures (e.g., discectomy, intradiscal electrothermal therapy, intradiscal radiofrequency, artificial disc replacement, and interbody fusion) on the lumbar spine
Any planned or elective surgery during the study period
Any known active infections, including hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV)
Current or prior history of any spinal infection (i.e., discitis, septic arthritis, or epidural abscess)
Any lumbar intradiscal injection procedure (e.g., injection of corticosteroids, methylene blue, dextrose, etc.), myelograms, discography, and/or lumbar epidural or transforaminal injections with corticosteroids or nerve-blocking anesthetics (e.g, lidocaine, bupivacaine) within 3 months prior to study start
Any electrotherapy (i.e., transcutaneous electrical nerve stimulation \[TENS\] unit) or acupuncture for DDD within 4 weeks prior to study medication injection
History of or current/pending disability claim, workers' compensation, or litigation(s) related to back pain/injury
Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at any investigative site, or are directly affiliated with the study at any investigative site
Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study, or who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of said employees responsible for the conduct of the study
