Healthy Participants
Conditions
Brief summary
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.
Interventions
DRUGCSL312
Factor XIIa antagonist monoclonal antibody for subcutaneous use
Sponsors
CSL Behring
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Male or female 18 to 55 years of age * Body weight in the range of ≥ 50 kg and ≤ 100 kg, with a body mass index (BMI) of ≥ 18 kg/m2 and ≤ 30 kg/m2
Exclusion criteria
* Received any live viral or bacterial vaccinations within 8 weeks of Screening or is expected to receive any live virus or bacterial vaccinations during the study or up to 4 months after last administration of the investigational product. * Evidence of current active infection, including severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). * Blood pressure or pulse rate measurements outside the normal range for the subject's age
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number and percentage of subjects experiencing serious adverse events (SAEs) | Up to 85 days post-dose |
| Number and percentage of subjects experiencing adverse events of special interest (AESIs) | 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 |
| Number and percentage of subjects developing Anti-CSL312 antibodies | 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 |
| Time to maximum plasma concentration (Tmax) of CSL312 | Up to 85 days post-dose |
| Number and percentage of subjects experiencing adverse events (AEs) | Up to 85 days post-dose |
Countries
United States
Outcome results
None listed