This is a randomized, double-blind, placebo-controlled, dose-escalation, phase I study for the assessment of safety, tolerability and pharmacokinetics of single ascending doses of MOR106 in healthy male subjects and multiple ascending doses in subjects with moderate to severe atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
SGS LSS Clinical Pharmacology Unit
Antwerp, Belgium
St Johns Hospital
Budapest, Hungary
• Arensia Phase I unit
Chisinau, Moldova
Arensia Phase I unit
Bucharest, Romania
Difference as compared to placebo in the number of subjects with treatment-emergent adverse events
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Time frame: Up to 99 days after dosing
Difference as compared to placebo in the number of subjects with deviating physical examination results
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Time frame: Up to 99 days after dosing
Difference as compared to placebo in the number of subjects with abnormal vital signs
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Time frame: Up to 99 days after dosing
Difference as compared to placebo in the number of subjects with abnormal 12-lead ECG results
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Time frame: Up to 99 days after dosing
Difference as compared to placebo in the number of subjects with abnormal laboratory findings
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Time frame: Up to 99 days after dosing
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Difference as compared to placebo in the occurrence of infusion related reactions
To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo
Time frame: Up to 99 days after dosing
Serum concentration (Cinf) of MOR106
To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis
Time frame: up to 99 days after dosing
Area under the curve (AUC) of MOR106
To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis
Time frame: up to 99 days after dosing
terminal elimination half-life (t1/2) of MOR106
To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis
Time frame: up to 99 days after dosing
total serum clearance (CL) of MOR106
To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis
Time frame: up to 99 days after dosing
volume of distribution at steady state (Vss) of MOR106
To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis
Time frame: up to 99 days after dosing
The presence of anti-drug antibodies in serum over time after single intravenous dose
To assess the presence of anti-drug antibodies as a measure of immunogenicity after single administration of MOR106 and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis
Time frame: up to 9 days after dosing