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

CSL Behring

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Biological: CSL324

Study type: Interventional

Funder types: Industry

Identifiers

NCT04570267

CSL324_1003

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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32 participants in 3 patient groups, including a placebo group

CSL324 (Low dose)

Experimental group

Description:

One low dose of CSL324 administered subcutaneously on Day 1

Treatment:

Biological: CSL324

CSL324 (High dose)

Experimental group

Description:

One high dose of CSL324 administered subcutaneously on Day 1

Treatment:

Biological: CSL324

Placebo

Placebo Comparator group

Description:

One dose of placebo administered subcutaneously on Day 1

Treatment:

Drug: Placebo