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A Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip Osteoarthritis

Degenerative Osteoarthritis Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Determine the Efficacy, Safety, and Dosing of TG-C in Adult Subjects With Symptomatic Early Hip Osteoarthritis

Clinical Trial Summary

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Determine the Efficacy, Safety, and Dosing of TG-C in Adult Subjects with Symptomatic Early Hip Osteoarthritis. TG-C will be administered to the target hip by a single ultrasound (or fluoroscopy)-guided, intra-articular injection with image capture showing correct injection of study drug into the femoroacetabular joint. Patients will be followed for 12 months for safety and efficacy.

Clinical Trial Description

This protocol is designed to assess the safety and efficacy of TG-C in treating symptoms of osteoarthritis of the hip and determining disease modifying effects of TG-C. TG-C will be compared to normal saline as a control. Safety will be evaluated by observation of the injection site for irritation or other effects, the incidence and severity of adverse events, and changes in physical examination findings, radiographic criteria, and laboratory tests. Patients will be followed for 12 months for both safety and efficacy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05276011
Study type Interventional
Source Kolon TissueGene, Inc.
Contact Diana Halim, MS
Phone (301) 921-6000
Email dhalim@tissuegene.com
Status Not yet recruiting
Phase Phase 2
Start date October 2024
Completion date October 2025
View Details
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