Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects

Study Overview
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Brief Summary
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Study CSL324_1003 is a single center, randomized, double-blind, placebo-controlled study designed to characterize and compare the PK properties and safety of a single subcutaneous dose of CSL324 in healthy Japanese and White subjects.

Official Title
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A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects

Conditions
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Healthy

Intervention / Treatment
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* Biological: CSL324
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female Japanese or White subjects aged 20 and 55 years, inclusive Body weight of at least 45 kg to 100 kg, inclusive Body mass index of 18.0 to 32.0 kg/m2, inclusive Exclusion Criteria: A clinically significant medical condition, disorder, or disease of any organ system. Concurrent diagnosis of malignancy or history of malignancy (except for nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for at least 3 months before Screening). Immunosuppressive conditions and / or currently taking immunosuppressive or immunomodulative therapy. Clinically significant abnormalities on physical examination, vital signs, or laboratory assessments, or neutropenia (defined as absolute neutrophil count < 2.0 × 109/L). History of chronic or recurrent infections, clinical signs of active infection and / or fever, current / history of serious infection or hospitalized or received IV antibiotics for an infection in previous 2 months.

Ages Eligible for Study
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Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSL324 (Low dose)<br>One low dose of CSL324 administered subcutaneously on Day 1 | Biological: CSL324<br>* Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection<br>* Other names: Recombinant Anti G-CSF Receptor Monoclonal Antibody;|
| Experimental: CSL324 (High dose)<br>One high dose of CSL324 administered subcutaneously on Day 1 | Biological: CSL324<br>* Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection<br>* Other names: Recombinant Anti G-CSF Receptor Monoclonal Antibody;|
| Placebo Comparator: Placebo<br>One dose of placebo administered subcutaneously on Day 1 | Drug: Placebo<br>* Sterile solution of CSL324 formulation buffer for injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) of CSL324 in serum |  | From Day 1 to Day 56 | 
| Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL324 in serum |  | From Day 1 to Day 56 | 
| Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL324 in serum |  | From Day 1 to Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with treatment-emergent adverse events (TEAEs) by incidence, by severity, and by causality |  | Up to Day 56 | 
| Percentage of subjects with TEAEs by incidence, by severity, and by causality |  | Up to Day 56 | 
| Number of subjects with adverse events localized to the administration site by incidence, by severity, and by causality |  | Up to Day 7 | 
| Percentage of subjects with adverse events localized to the administration site by incidence, by severity, and by causality |  | Up to Day 7 | 
| Time to reach Cmax (Tmax) for CSL324 in serum |  | From Day 1 to Day 56 | 
| Terminal half-life (t1/2) for CSL324 in serum |  | From Day 1 to Day 56 | 
| Apparent clearance (CL/F) for CSL324 in serum |  | From Day 1 to Day 56 | 
| Apparent volume of distribution (Vz/F) for CSL324 in serum |  | From Day 1 to Day 56 | 
| Number of subjects with or without anti-CSL324 antibodies |  | Up to Day 56 | 
| Percentage of subjects with or without anti-CSL324 antibodies |  | Up to Day 56 |