Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, parallel-group, phase 1, single center study to assess the relative bioavailability of CSL312 administered subcutaneously via a prefilled syringe assembled to an autoinjector compared to a prefilled syringe assembled to a needle safety device in healthy, adult subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSL312 AI Abdomen | Experimental | CSL312 administered subcutaneously (SC) in the abdomen via a prefilled syringe assembled to an autoinjector (AI) |
|
| CSL312 AI Thigh | Experimental | CSL312 administered SC in the thigh via a prefilled syringe assembled to an AI |
|
| CSL312 AI Arm | Experimental | CSL312 administered SC in the upper arm via a prefilled syringe assembled to an AI |
|
| CSL312 NSD Abdomen | Experimental | CSL312 administered SC in the abdomen via a prefilled syringe assembled to a needle safety device (NSD) |
|
| CSL312 NSD Thigh | Experimental | CSL312 administered SC in the thigh via a prefilled syringe assembled to a NSD |
|
| CSL312 NSD Arm | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL312 | Drug | Factor XIIa antagonist monoclonal antibody for subcutaneous use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of CSL312 | Up to 85 days post-dose | |
| Area under the concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC0-inf) of CSL312 | Up to 85 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of subjects experiencing adverse events (AEs) | Up to 85 days post-dose | |
| Number and percentage of subjects experiencing serious adverse events (SAEs) | Up to 85 days post-dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States |
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
Proposed research should seek to answer a previously unanswered important medical or scientific question.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
CSL312 administered SC in the upper arm via a prefilled syringe assembled to a NSD
|
|
| Number and percentage of subjects experiencing adverse events of special interest (AESIs) | Up to 85 days post-dose |
| Number and percentage of subjects developing Anti-CSL312 antibodies | Up to 85 days post-dose |
| Number and percentage of subjects with clinically significant laboratory abnormalities that are reported as AEs | Up to 85 days post-dose |
| Number and percentage of subjects with injection site reactions by severity | Up to 48 hours post-injection |
| Time to maximum plasma concentration (Tmax) of CSL312 | Up to 85 days post-dose |
| AUC from time 0 to the last measurable concentration (AUC0-last) of CSL312 | Up to 85 days post-dose |
| Half-life (t1/2) of CSL312 | Up to 85 days post-dose |
| Apparent clearance (CL/F) of CSL312 | Up to 85 days post-dose |
| Apparent volume of distribution (Vz/F) of CSL312 | Up to 85 days post-dose |