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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSL324 (Low dose) | Experimental | One low dose of CSL324 administered subcutaneously on Day 1 |
|
| CSL324 (High dose) | Experimental | One high dose of CSL324 administered subcutaneously on Day 1 |
|
| Placebo | Placebo Comparator | One dose of placebo administered subcutaneously on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL324 | Biological | Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research Ltd | Randwick | Australia |
CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
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.
IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.
An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.
The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
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| Placebo | Drug | Sterile solution of CSL324 formulation buffer for injection |
|
| 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 |