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

NCT05454020 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-05-09

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Xgene Pharmaceutical Group

    lead INDUSTRY

Principal Investigators

  • Guy Ludbrook · PARC Clinical research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2023-01-23
Completion
2023-03-21

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05454020 on ClinicalTrials.gov