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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04570267
Recruitment Status : Completed
First Posted : September 30, 2020
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Biological: CSL324 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects
Actual Study Start Date : October 8, 2020
Actual Primary Completion Date : November 17, 2021
Actual Study Completion Date : December 9, 2021

Arm Intervention/treatment
Experimental: CSL324 (Low dose)
One low dose of CSL324 administered subcutaneously on Day 1
Biological: CSL324
Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection
Other Name: Recombinant Anti G-CSF Receptor Monoclonal Antibody

Experimental: CSL324 (High dose)
One high dose of CSL324 administered subcutaneously on Day 1
Biological: CSL324
Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection
Other Name: Recombinant Anti G-CSF Receptor Monoclonal Antibody

Placebo Comparator: Placebo
One dose of placebo administered subcutaneously on Day 1
Drug: Placebo
Sterile solution of CSL324 formulation buffer for injection




Primary Outcome Measures :
  1. Maximum concentration (Cmax) of CSL324 in serum [ Time Frame: From Day 1 to Day 56 ]
  2. Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL324 in serum [ Time Frame: From Day 1 to Day 56 ]
  3. Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL324 in serum [ Time Frame: From Day 1 to Day 56 ]

Secondary Outcome Measures :
  1. Number of subjects with treatment-emergent adverse events (TEAEs) by incidence, by severity, and by causality [ Time Frame: Up to Day 56 ]
  2. Percentage of subjects with TEAEs by incidence, by severity, and by causality [ Time Frame: Up to Day 56 ]
  3. Number of subjects with adverse events localized to the administration site by incidence, by severity, and by causality [ Time Frame: Up to Day 7 ]
  4. Percentage of subjects with adverse events localized to the administration site by incidence, by severity, and by causality [ Time Frame: Up to Day 7 ]
  5. Time to reach Cmax (Tmax) for CSL324 in serum [ Time Frame: From Day 1 to Day 56 ]
  6. Terminal half-life (t1/2) for CSL324 in serum [ Time Frame: From Day 1 to Day 56 ]
  7. Apparent clearance (CL/F) for CSL324 in serum [ Time Frame: From Day 1 to Day 56 ]
  8. Apparent volume of distribution (Vz/F) for CSL324 in serum [ Time Frame: From Day 1 to Day 56 ]
  9. Number of subjects with or without anti-CSL324 antibodies [ Time Frame: Up to Day 56 ]
  10. Percentage of subjects with or without anti-CSL324 antibodies [ Time Frame: Up to Day 56 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570267


Locations
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Australia
Scientia Clinical Research Ltd
Randwick, Australia
Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Director CSL Behring
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT04570267    
Other Study ID Numbers: CSL324_1003
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 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.
Access Criteria:

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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No