Lumbar Disc Herniation Clinical Trial
Official title:
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
The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in subjects with lumbar disc herniation.
This study was a first-in-human, open-label, non-controlled single ascending dose study of
KTP-001 in male and female subjects between the ages of 30 and 70 years with a single
herniated lumbar disc. After obtaining informed consent, subjects were evaluated during a
screening period of no more than 3 weeks (21 days). This study was conducted in 10 centers in
the US.
Subjects that met all screening requirements and inclusion criteria and none of the exclusion
criteria were enrolled into the study. Overall, 24 subjects were enrolled and treated: 6
subjects in each cohort. Cohort 1 received a 5 μg/disc dose of KTP-001 by intradiscal
injection. Following administration of study drug, subjects were confined to the study center
for 24 hours to collect data for safety and efficacy measures and collect blood samples for
safety, PK evaluation, exploratory PD and anti-KTP-001 antibody and then returned for further
assessments at various intervals from weeks 1 through to month 24.
After all subjects in Cohort 1 had received study drug, safety measures were evaluated by a
Data and Safety Monitoring Board (DSMB) to determine whether to escalate KTP-001
administration to the next dose level. If appropriate, Cohort 2 subjects received 15 μg/disc
of KTP-001, Cohort 3 subjects received 50 μg/disc of KTP-001, and Cohort 4 subjects received
150 μg/disc of KTP-001 by intradiscal injection. All safety, PK, and exploratory efficacy
assessments were performed for the subjects in the subsequent cohorts as were performed for
Cohort 1.
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