This is a Phase I dose escalation study to assess the safety, tolerability and activity of three different strengths of topical KX01 in the treatment of patients with plaque-type psoriasis.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Adverse event at Stage 1
Timeframe: Day 50
Adverse event at Stage 2
Timeframe: Day 43
Adverse event at Stage 3
Timeframe: Day 29
Adverse event at Stage 4
Timeframe: 28 days after the end of cycle 4 treatment (each cycle is 7 days)
Local tolerability score at Stage 1
Timeframe: Day 50
Local tolerability score at Stage 2
Timeframe: Day 43
Local tolerability score at Stage 3
Timeframe: Day 29
Local tolerability score at Stage 4
Timeframe: 28 days after the end of cycle 4 treatment (each cycle is 7 days)
Vital signs at Stage 1
Timeframe: Day 50
Vital signs at Stage 2
Timeframe: Day 43
Vital signs at Stage 3
Timeframe: Day 29
Vital signs at Stage 4
Timeframe: 28 days after the end of cycle 4 treatment (each cycle is 7 days)
12-lead ECG at Stage 1
Timeframe: Day 36
12-lead ECG at Stage 2
Timeframe: Day 29
12-lead ECG at Stage 3
Timeframe: Day 29
12-lead ECG at Stage 4
Timeframe: 28 days after the end of cycle 4 treatment (each cycle is 7 days)
Hematology assessments at Stage 1
Timeframe: Day 36
Clinical chemistry assessments at Stage 1
Timeframe: Day 36
Urinalysis assessments at Stage 1
Timeframe: Day 36
Hematology assessments at Stage 2
Timeframe: Day 29
Clinical chemistry assessments at Stage 2
Timeframe: Day 29
Urinalysis assessments at Stage 2
Timeframe: Day 29
Hematology assessments at Stage 3
Timeframe: Day 29
Clinical chemistry assessments at Stage 3
Timeframe: Day 29
Urinalysis assessments at Stage 3
Timeframe: Day 29
Hematology assessments at Stage 4
Timeframe: 28 days after the end of cycle 4 treatment (each cycle is 7 days)
Clinical chemistry assessments at Stage 4
Timeframe: 28 days after the end of cycle 4 treatment (each cycle is 7 days)
Urinalysis assessments at Stage 4
Timeframe: 28 days after the end of cycle 4 treatment (each cycle is 7 days)