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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04570267
• Other study ID #: CSL324_1003
• Status: Completed
• Phase: Phase 1
• Start date: October 8, 2020
• Est. completion date: December 9, 2021

Study information

• Verified date: October 2022
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 9, 2021
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• CSL324
Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection

Drug:
• Placebo
Sterile solution of CSL324 formulation buffer for injection

Locations

Country	Name	City	State
Australia	Scientia Clinical Research Ltd	Randwick

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

Australia, 

Outcome

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