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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504450-35 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAN10 single ascending dose | Experimental | A single dose of CAN10 will be administered intravenously (IV) to healthy subjects. |
|
| CAN10 single ascending dose - placebo | Placebo Comparator | A single dose of matching placebo will be administered intravenously (IV) to healthy subjects. |
|
| CAN10 multiple ascending dose | Experimental | Multiple doses of CAN10 will be administered subcutaneously (SC) to subjects with mild to moderate plaque psoriasis |
|
| CAN10 multiple ascending dose - placebo | Placebo Comparator | Multiple doses of matching placebo will be administered subcutaneously (SC) to subjects with mild to moderate plaque psoriasis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAN10 | Biological | Single dose intravenous or Multiple doses subcutaneously |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the day of the first dose until day 57 after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Area under plasma concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) after single (IV) dosing | 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 |
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Inclusion Criteria:
Additionally for subjects with plaque psoriasis only:
Exclusion Criteria:
History or presence of:
Clinically significant illness, medical/surgical procedure, or trauma within 4 weeks before the first dose of study drug.
Ongoing opportunistic or systemic infections
A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antigen or antibodies at screening.
Additionally for subjects with plaque psoriasis only:
Psoriasis other than a plaque variant.
Any sign of infection of any of the psoriatic lesions.
Use of any of the following treatments within the indicated washout period before the first dose of study drug:
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| Name | Affiliation | Role |
|---|---|---|
| Manuela Casjens, MD | CRS Clinical Research Services Berlin GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Berlin GmbH | Berlin | 13627 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38563353 | Derived | Mulholland M, Depuydt MAC, Jakobsson G, Ljungcrantz I, Grentzmann A, To F, Bengtsson E, Jaensson Gyllenback E, Gronberg C, Rattik S, Liberg D, Schiopu A, Bjorkbacka H, Kuiper J, Bot I, Slutter B, Engelbertsen D. Interleukin-1 receptor accessory protein blockade limits the development of atherosclerosis and reduces plaque inflammation. Cardiovasc Res. 2024 May 7;120(6):581-595. doi: 10.1093/cvr/cvae046. |
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| CAN10 - Placebo | Biological | Single dose intravenous or Multiple doses subcutaneously |
|
| 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) | 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 | 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 | 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 | 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 | From the day of the first dose until day 57 after the last dose |
| Assessment of the total clearance (CL) following single (IV) dosing) | From the day of dosing (day 1) until day 57 after dosing |
| Assessment of the volume of distribution (Vd) following single (IV) dosing | 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 | 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 | From the day of the first dose until day 57 after the last dose |