This is a first-in-human, randomized, double- blind, placebo-controlled, dose escalation study to investigate how different doses of CAN10 are tolerated, taken up by the body and how long CAN10 stays in the body. In the first part of the study, the single ascending dose (SAD) cohorts, CAN10 will be given as a single intravenous dose to healthy subjects. In the second part of the study, the multiple ascending dose (MAD) cohorts, CAN10 will be given as repeated subcutaneous doses to participants with mild to moderate plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Single dose intravenous or Multiple doses subcutaneously
Single dose intravenous or Multiple doses subcutaneously
CRS Clinical Research Services Berlin GmbH
Berlin, Germany
To investigate the safety and tolerability of single and multiple ascending doses of CAN10
Frequency, seriousness, and intensity of treatment-emergent adverse events (TEAEs) in subjects receiving single and multiple doses of CAN10
Time frame: From the day of the first dose until day 57 after the last dose
Assessment of Area under plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) after single (IV) dosing
Time frame: From the day of dosing (day 1) until day 57 after dosing
Assessment of AUC from time zero to last measurable serum concentration (AUClast) following single (IV) and multiple (SC) dosing
Time frame: From the day of the first dose until day 57 after the last dose
Assessment of AUC from time 0 to 336 hours post dose (i.e., AUC over a 2-week interval) after multiple (SC) dosing on Day 36 (AUC0-336,MD)
Time frame: From the last dose until 336 hours after the last dose
Assessment of the maximum observed concentration (Cmax) following single (IV) and multiple (SC) dosing
Time frame: From the day of the first dose until day 57 after the last dose
Assessment of time to maximum observed serum concentration (Tmax) following single (IV) and multiple (SC) dosing
Time frame: From the day of the first dose until day 57 after the last dose
Assessment of the terminal elimination rate constant (λz) following single (IV) and multiple (SC) dosing
Time frame: From the day of the first dose until day 57 after the last dose
Assessment of the terminal halflife (t1/2) following single (IV) and multiple (SC) dosing
Time frame: From the day of the first dose until day 57 after the last dose
Assessment of the total clearance (CL) following single (IV) dosing)
Time frame: From the day of dosing (day 1) until day 57 after dosing
Assessment of the volume of distribution (Vd) following single (IV) dosing
Time frame: From the day of dosing (day 1) until day 57 after dosing
Assessment of total clearance following extravascular administration (CL/F) following multiple (SC) dosing
Time frame: From the day of the first dose until day 57 after the last dose
Assessment of volume of distribution following extravascular administration (Vd/F) following multiple (SC) dosing
Time frame: From the day of the first dose until day 57 after the last dose
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