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.

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.