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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: CSL324; Drug: Placebo

• Registration Number: NCT04570267
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-09-30
• Study Start: 2020-10-08
• Primary Completion: 2021-11-17
• Study Completion: 2021-12-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CSL324 (Low dose)	CSL324	One low dose of CSL324 administered subcutaneously on Day 1
CSL324 (High dose)	CSL324	One high dose of CSL324 administered subcutaneously on Day 1
Placebo	Placebo	One dose of placebo administered subcutaneously on Day 1

Primary Outcome Measures

Name	Time	Method
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
Maximum concentration (Cmax) 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

Name	Time	Method
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
Apparent volume of distribution (Vz/F) for CSL324 in serum	From Day 1 to Day 56
Number of subjects with treatment-emergent adverse events (TEAEs) by incidence, by severity, and by causality	Up 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
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
Percentage of subjects with TEAEs by incidence, by severity, and by causality	Up to Day 56

Trial Locations

Locations (1)

Scientia Clinical Research Ltd; 🇦🇺 Randwick, Australia