NCT03477487

Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain

Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Xalud Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of Safety, Tolerability, and Efficacy of XT-150, a plasmid DNA with a variant of human IL-10 transgene. XT-150 will be a single injection into the knee synovial capsule for the Treatment of Osteoarthritic Pain.

Detailed description

Phase 1 dose escalation study to evaluate the safety, tolerability, and efficacy of a plasmid DNA encoding a variant of human IL-10. This 6-month study will follow subjects with severe osteoarthritis of the knee. Safety labs, physical exams, and blood levels of the IL-10 variant will be assessed for tolerability and any adverse events associated with the treatment.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
BIOLOGICAL	XT-150	Human IL-10 variant transgene in a plasmid DNA vector

Timeline

• Start date: 2018-06-08
• Primary completion: 2019-07-19
• Completion: 2019-09-30
• First posted: 2018-03-26
• Last updated: 2019-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study