NCT05454020

A Study of Topical XG004 in Participants With Osteoarthritis of the Knee

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dosing, Ascending-Dose Study Evaluating the Safety, Tolerability and Pharmacokinetics of XG004 Applied Topically in Participants With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Xgene Pharmaceutical Group · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is phase 1 placebo controlled study to evaluate the safety, tolerability and pharmacokinetics of XG004 applied topically in participants with osteoarthritis of the knee

Detailed description

The study will consist of a 4-week Screening period, an 7-day Treatment period and a 7-day Safety follow-up period that will be conducted by telephone for each Cohort. Up to 32 participants with OA of the knee will be enrolled into 6 cohorts sequentially and assigned treatment on a 3:1 (XG004: placebo) ratio.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	XG004	XG004 gel in two concentrations (5% and 10%) will be applied topically once-daily, twice-daily or three times daily in a designated area of the study knee.
DRUG	Placebo	Placebo gel will be applied topically once-daily, twice-daily or three times daily in a designated area of the study knee.

Timeline

• Start date: 2022-06-07
• Primary completion: 2023-01-23
• Completion: 2023-03-21
• First posted: 2022-07-12
• Last updated: 2023-05-09

Locations

1 site across 1 country: Australia