Clinical trial NCT04570267: Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2020-09-30
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum concentration (Cmax) of CSL324 in serum
timeFrame: From Day 1 to Day 56
measure: Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL324 in serum
timeFrame: From Day 1 to Day 56
measure: Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL324 in serum
timeFrame: From Day 1 to Day 56
Secondary outcomes:
measure: Number of subjects with treatment-emergent adverse events (TEAEs) by incidence, by severity, and by causality
timeFrame: Up to Day 56
measure: Percentage of subjects with TEAEs by incidence, by severity, and by causality
timeFrame: Up to Day 56
measure: Number of subjects with adverse events localized to the administration site by incidence, by severity, and by causality
timeFrame: Up to Day 7
measure: Percentage of subjects with adverse events localized to the administration site by incidence, by severity, and by causality
timeFrame: Up to Day 7
measure: Time to reach Cmax (Tmax) for CSL324 in serum
timeFrame: From Day 1 to Day 56
measure: Terminal half-life (t1/2) for CSL324 in serum
timeFrame: From Day 1 to Day 56
measure: Apparent clearance (CL/F) for CSL324 in serum
timeFrame: From Day 1 to Day 56
measure: Apparent volume of distribution (Vz/F) for CSL324 in serum
timeFrame: From Day 1 to Day 56
measure: Number of subjects with or without anti-CSL324 antibodies
timeFrame: Up to Day 56
measure: Percentage of subjects with or without anti-CSL324 antibodies
timeFrame: Up to Day 56
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Scientia Clinical Research Ltd
Study officials:
affiliation: CSL Behring
name: Study Director
role: STUDY_DIRECTOR
References: