Assessing the Safety and Tolerability of CSL730 in Healthy Caucasian and Japanese Adults

Recruitment & Eligibility

Inclusion Criteria

Healthy males or females (postmenopausal or surgically sterile only) aged ≥ 20 to ≤ 55 years and of Caucasian or Japanese descent

Exclusion Criteria

Evidence of a clinically significant medical condition, disorder, or disease as judged by Investigator and / or study Medical Monitor.
History of asthma (with the exception of childhood asthma that has resolved), chronic obstructive pulmonary disease, or recurrent or current respiratory infections; splenectomy; or recurrent or current gastrointestinal infections.
Evidence of active or latent tuberculosis.
Known or suspected hypersensitivity to the IP, to any excipients of the IP, humanized monoclonal antibodies, or Fc fusion protein therapeutics.
History, or current diagnosis, of substance use disorder.
Any abnormal clinical laboratory values deemed clinically significant by the Investigator and / or study Medical Monitor.
Positive serology test result for human immunodeficiency virus antibody, hepatitis virus B surface antigen or hepatitis virus C antibody at Screening.
Donation or loss of ≥ 480 mL of whole blood within 2 months or donation of plasma within 14 days before Day -1.
Plans to participate in another investigational drug study while enrolled in this study, or has participated in any other investigational drug study in which they were known to have been administered a monoclonal antibody or biological IP within 4 months, any other investigational drug study within 60 days or > 3 investigational drug studies within 12 months before IP administration.

Study & Design

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
CSL730	CSL730	-

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with adverse events overall, and by causality and severity	Up to 8 weeks after infusion

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Area under the concentration-time curve from time 0 to the last collection time (AUC0-last) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Number of subjects with anti-CSL730 antibodies in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Maximum observed concentration (Cmax) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Time of maximum observed concentration (Tmax) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Terminal elimination half-life (T1/2) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Total systemic clearance (CL) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.
Volume of distribution during the elimination phase (Vz) of CSL730 in serum	Before study drug infusion and up to 56 days after the start of the infusion.

Recruitment & Eligibility