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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 : October 4, 2022
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Tracking Information
First Submitted Date  ICMJE September 25, 2020
First Posted Date  ICMJE September 30, 2020
Last Update Posted Date October 4, 2022
Actual Study Start Date  ICMJE October 8, 2020
Actual Primary Completion Date November 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
  • Maximum concentration (Cmax) of CSL324 in serum [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From Day 1 to Day 56 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
  • Number of subjects with treatment-emergent adverse events (TEAEs) by incidence, by severity, and by causality [ Time Frame: Up to Day 56 ]
  • Percentage of subjects with TEAEs by incidence, by severity, and by causality [ Time Frame: Up to Day 56 ]
  • Number of subjects with adverse events localized to the administration site by incidence, by severity, and by causality [ Time Frame: Up to Day 7 ]
  • Percentage of subjects with adverse events localized to the administration site by incidence, by severity, and by causality [ Time Frame: Up to Day 7 ]
  • Time to reach Cmax (Tmax) for CSL324 in serum [ Time Frame: From Day 1 to Day 56 ]
  • Terminal half-life (t1/2) for CSL324 in serum [ Time Frame: From Day 1 to Day 56 ]
  • Apparent clearance (CL/F) for CSL324 in serum [ Time Frame: From Day 1 to Day 56 ]
  • Apparent volume of distribution (Vz/F) for CSL324 in serum [ Time Frame: From Day 1 to Day 56 ]
  • Number of subjects with or without anti-CSL324 antibodies [ Time Frame: Up to Day 56 ]
  • Percentage of subjects with or without anti-CSL324 antibodies [ Time Frame: Up to Day 56 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: CSL324
    Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection
    Other Name: Recombinant Anti G-CSF Receptor Monoclonal Antibody
  • Drug: Placebo
    Sterile solution of CSL324 formulation buffer for injection
Study Arms  ICMJE
  • Experimental: CSL324 (Low dose)
    One low dose of CSL324 administered subcutaneously on Day 1
    Intervention: Biological: CSL324
  • Experimental: CSL324 (High dose)
    One high dose of CSL324 administered subcutaneously on Day 1
    Intervention: Biological: CSL324
  • Placebo Comparator: Placebo
    One dose of placebo administered subcutaneously on Day 1
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2020)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 9, 2021
Actual Primary Completion Date November 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04570267
Other Study ID Numbers  ICMJE CSL324_1003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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.

Current Responsible Party CSL Behring
Original Responsible Party Same as current
Current Study Sponsor  ICMJE CSL Behring
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director CSL Behring
PRS Account CSL Behring
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP