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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
PARC Clinical research
Adelaide, South Australia, Australia
To evaluate the safety and tolerability of topical XG004 applied to the study knee in Osteoarthritis (OA) participants through incidence of Treatment Emergent Adverse Events as assessed by CTCAE v5.0
Time frame: From baseline to end of treatment up to 14 days
To examine skin response
Skin safety and irritability assessment will be conducted after topical application of investigational product. All skin reactions at the applications sites will be examined and scored as per Modified Berger/Bowman Scoring Scale. Pain will be examined a 0-10 NRS (numerical rating scale) and higher scores mean a worse outcome.
Time frame: From day 1 to day 8
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments.
The following parameter is used for evaluation during PK assessments: Maximum concentration (Cmax)
Time frame: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments.
The following parameter is used for evaluation during PK assessments: Time to maximum concentration (Tmax)
Time frame: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
The following parameter is used for evaluation during PK assessments: Area under the drug concentration-time curve
Time frame: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
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The following parameter is used for evaluation during PK assessments: accumulation ratio (AR)
Time frame: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
The following parameter is used for evaluation during PK assessments: Apparent clearance
Time frame: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
The following parameter is used for evaluation during PK assessments: Apparent terminal half-life
Time frame: From baseline to end of treatment up to 8 days
To explore the penetration of XG004 into the synovial fluid of the knee. Synovial fluid samples will be evaluated for the drug concentrations.
Time frame: Day 8