NCT03282149

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

A Placebo-controlled, Preliminary Evaluation of Safety, Tolerability, and Efficacy of Ascending Doses of XT-150 for the Treatment of Osteoarthritic Pain

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Xalud Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain. Subjects for whom replacement knee surgery is recommended will be enrolled in the study. A single injection of a DNA plasmid with a variant Interleukin-10 (IL-10) transgene will be injected into the synovial capsule of the knee. This is a first in human, dose-range, safety and efficacy study.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
BIOLOGICAL	XT-150	IL-10 transgene DNA plasmid injected into the knee synovial capsule

Timeline

• Start date: 2018-03-21
• Primary completion: 2019-03-31
• Completion: 2019-06-15
• First posted: 2017-09-13
• Last updated: 2019-07-05

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study