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

Study Overview
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Brief Summary
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To assess the safety and tolerability of ascending doses of CSL730 after a single intravenous (IV) infusion in healthy Caucasian and Japanese subjects

Official Title
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A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous CSL730 in Healthy Caucasian and Japanese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Biological: CSL730
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSL730<br> | Biological: CSL730<br>* Solution for IV infusion<br>* Other names: Recombinant trivalent human IgG1 Fc multimer;|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Saline solution for IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with adverse events overall, and by causality and severity |  | Up to 8 weeks after infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) 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. | 
| 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. | 
| 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. | 
| Number of subjects with anti-CSL730 antibodies in serum |  | Before study drug infusion and up to 56 days after the start of the infusion. |