A Study to Compare the Pharmacokinetics of CSL312 Administered by Prefilled Syringe Assembled to Autoinjector to the Pharmacokinetics Administered by Prefilled Syringe Assembled to Needle Safety Device in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Randomized, Open-label, Parallel-group Study to Compare the Pharmacokinetic Properties of CSL312 Administered by Subcutaneous Prefilled Syringe Assembled to Autoinjector to Prefilled Syringe Assembled to Needle Safety Device in Healthy Adult Subjects

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: CSL312


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSL312 AI Abdomen<br>CSL312 administered subcutaneously (SC) in the abdomen via a prefilled syringe assembled to an autoinjector (AI) | Drug: CSL312<br>* Factor XIIa antagonist monoclonal antibody for subcutaneous use<br>* Other names: Gardacimab;|
| Experimental: CSL312 AI Thigh<br>CSL312 administered SC in the thigh via a prefilled syringe assembled to an AI | Drug: CSL312<br>* Factor XIIa antagonist monoclonal antibody for subcutaneous use<br>* Other names: Gardacimab;|
| Experimental: CSL312 AI Arm<br>CSL312 administered SC in the upper arm via a prefilled syringe assembled to an AI | Drug: CSL312<br>* Factor XIIa antagonist monoclonal antibody for subcutaneous use<br>* Other names: Gardacimab;|
| Experimental: CSL312 NSD Abdomen<br>CSL312 administered SC in the abdomen via a prefilled syringe assembled to a needle safety device (NSD) | Drug: CSL312<br>* Factor XIIa antagonist monoclonal antibody for subcutaneous use<br>* Other names: Gardacimab;|
| Experimental: CSL312 NSD Thigh<br>CSL312 administered SC in the thigh via a prefilled syringe assembled to a NSD | Drug: CSL312<br>* Factor XIIa antagonist monoclonal antibody for subcutaneous use<br>* Other names: Gardacimab;|
| Experimental: CSL312 NSD Arm<br>CSL312 administered SC in the upper arm via a prefilled syringe assembled to a NSD | Drug: CSL312<br>* Factor XIIa antagonist monoclonal antibody for subcutaneous use<br>* Other names: Gardacimab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |