The first-in-human study will be performed in healthy volunteers and patients with a chronic inflammatory skin disease. The primary objective is to evaluate the safety, tolerability and pharmacokinetics of increasing doses of AX-202 infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
58
Medicines Evaluation Unit
Manchester, Wythenshawe, United Kingdom
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of adverse events.
Number of patients with AE's
Time frame: Until 100 days after last dose
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by physical examinations.
Number of patients with clinically significant findings on physical examinations
Time frame: Until 100 days after last dose
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by assessment of infusion related reactions
Number of patients with infusion related reactions
Time frame: Until 100 days after last dose
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of vital signs
Number of patients with clinically significant changes from baseline in vital signs
Time frame: Until 100 days after last dose
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by monitoring of clinical laboratory parameters
Number of patients with clinically significant change from baseline in clinical laboratory test results.
Time frame: Until 100 days after last dose
To assess the safety and tolerability of a single ascending IV dose of AX-202 in healthy subjects and multiple ascending IV doses of AX-202 in patients with mild to moderate chronic plaque psoriasis by ECG monitoring
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Number of patients with clinically significant change from baseline in ECG parameters
Time frame: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Calculation of maximum serum concentration (Cmax) of AX-202
Time frame: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Calculation of time to maximum concentration (tmax) of AX-202
Time frame: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Calculation of the area under the plasma concentration-time curve (AUC)
Time frame: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Calculation of the half-life of AX-202
Time frame: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Calculation of the clearance (CL) of AX-202
Time frame: Until 100 days after last dose
To characterise systemic PK of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Calculation of volume of distribution at steady state (Vss)
Time frame: Until 100 days after last dose
To evaluate immunogenicity of AX-202 after a single ascending IV dose in healthy subjects and after multiple ascending IV doses in patients with mild to moderate chronic plaque psoriasis.
Number of participants with anti-drug antibodies against AX-202
Time frame: Until 100 days after last dose