First Human Dose Study of Anti-IL-20 in Psoriasis: A Study of Safety, Tolerability and Early Signals of Biologic and Clinical Effects

Observed toxicity using the US National Cancer Institute's common terminology criteria for adverse events (CTCAE) - MD expansion phase

Time frame: from week 0 until end of trial observation period at week 22

Improvement psoriasis area and severity index score by 75% (PASI75) - SD and MD phases

Time frame: SD: at weeks 1, 3, 9, 13 and 16. MD: at weeks 1, 3, 5, 7, 9, 15, 22

Pharmacokinetics (the rate at which the body eliminates the trial drug) - SD and MD phases

Time frame: SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7)

Pharmacokinetics (the rate at which the body eliminates the trial drug) - MD expansion phase

Time frame: prior to dosing (week 1) and at each dosing visit (week 2-7)

Pharmacodynamics (the effect of the investigated drug on the body) - SD and MD phases

Time frame: SD: Prior to dosing (week 1) and through 24 hours and at each visit (week 1-3, 5, 9, 13 and 16). MD: Prior to dosing and at each dosing visit (week 1, 3, 5, 7)

Pharmacodynamics (the effect of the investigated drug on the body) - MD expansion phase

Time frame: prior to dosing (week 1) and at each dosing visit (week 2-7)