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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: CSL324; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Randwick, Australia
    • Scientia Clinical Research Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: CSL Behring

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): November 17, 2021
• Study Completion (Actual): December 9, 2021

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CSL324_1003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD 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.

• IPD Sharing 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.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No