Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects

Study Overview
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Brief Summary
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This phase 1, randomized, double-blind, placebo-controlled study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of CSL730 administered by subcutaneous (SC) injection or SC infusion in healthy adult 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 Subcutaneous CSL730 in Healthy Adult Subjects

Conditions
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Immune Complex-mediated Autoimmune Diseases

Intervention / Treatment
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* Biological: CSL730
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female adult subjects aged ≥ 18 to ≤ 55 years Females must be either postmenopausal or sterile Body weight between ≥ 50 and ≤ 110 kg and body mass index between ≥ 18.0 kg/m2 and ≤ 30 kg/m2 Exclusion Criteria: History or current evidence of a clinically significant medical condition, disorder, or disease, including but not limited to any of the following: hepatic (hepatitis, cirrhosis, or history of liver disease, drug reaction, or aminotransaminase elevations, if known); biliary; renal; cardiac; bronchopulmonary; vascular; hematologic; gastrointestinal; allergy; endocrine / metabolic (diabetes, thyroid disorders, adrenal disease); neurologic (including history of migraine); psychiatric; immunologic; dermatologic; oncologic (subjects with resected cervical or skin cancer [except melanoma] who have had no evidence of disease in the last 5 years are eligible), that precludes designation of healthy subjects as judged by the Investigator History or evidence of congenital or acquired immunosuppressive condition(s), including positive serology for human immunodeficiency virus infection or taking immunosuppressive agents. Evidence of active or latent tuberculosis Hospitalization within 3 months before IP administration or planned hospitalization at any time during the study. History of any drug allergy, hypersensitivity (excluding hay fever) or intolerance to latex or any drug product A positive test result for drugs of abuse. Smokers within 3 months before Screening.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSL730 (dose 1 with premedication)<br>administered as a single dose by subcutaneous (SC) injection or by SC infusion | Biological: CSL730<br>* solution for injection and infusion<br>* Other names: Recombinant trivalent human IgG1 Fc multimer;|
| Experimental: CSL730 (dose 2 with premedication)<br>administered as a single dose by SC injection or by SC infusion | Biological: CSL730<br>* solution for injection and infusion<br>* Other names: Recombinant trivalent human IgG1 Fc multimer;|
| Experimental: CSL730 (dose 3 with premedication)<br>administered as a single dose by SC injection or by SC infusion | Biological: CSL730<br>* solution for injection and infusion<br>* Other names: Recombinant trivalent human IgG1 Fc multimer;|
| Experimental: CSL730 (dose 1 without premedication)<br>administered as a single dose by SC injection or by SC infusion | Biological: CSL730<br>* solution for injection and infusion<br>* Other names: Recombinant trivalent human IgG1 Fc multimer;|
| Experimental: CSL730 (dose 2 without premedication)<br>administered as a single dose by SC injection or by SC infusion | Biological: CSL730<br>* solution for injection and infusion<br>* Other names: Recombinant trivalent human IgG1 Fc multimer;|
| Experimental: CSL730 (dose 3 without premedication)<br>administered as a single dose by SC injection or by SC infusion | Biological: CSL730<br>* solution for injection and infusion<br>* Other names: Recombinant trivalent human IgG1 Fc multimer;|
| Experimental: CSL730 (dose 4 without premedication)<br>administered as a single dose by SC injection or by SC infusion | Biological: CSL730<br>* solution for injection and infusion<br>* Other names: Recombinant trivalent human IgG1 Fc multimer;|
| Experimental: CSL730 (dose 5 without premedication)<br>administered as a single dose by SC injection or by SC infusion | Biological: CSL730<br>* solution for injection and infusion<br>* Other names: Recombinant trivalent human IgG1 Fc multimer;|
| Experimental: CSL730 (dose 6 without premedication)<br>administered as a single dose by SC injection or by SC infusion | Biological: CSL730<br>* solution for injection and infusion<br>* Other names: Recombinant trivalent human IgG1 Fc multimer;|
| Experimental: CSL730 (dose 7 without premedication)<br>administered as a single dose by SC injection or by SC infusion | Biological: CSL730<br>* solution for injection and infusion<br>* Other names: Recombinant trivalent human IgG1 Fc multimer;|
| Placebo Comparator: Placebo<br>A solution matching the excipient profile of CSL730 without the active substance administered as a single dose by SC injection or by SC infusion | Drug: Placebo<br>* A solution matching the excipient profile of CSL730 without the active substance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity |  | Within 96 hours and up to 56 days after CSL730 administration | 
| Percent of subjects with TEAEs overall, by causality, and by severity |  | Within 96 hours and up to 56 days after CSL730 administration | 
| Number of subjects with localized administration site AEs overall, by causality, and by severity |  | Within 96 hours and up to 56 days after CSL730 administration | 
| Percent of subjects with localized administration site AEs overall, by causality, and by severity |  | Within 96 hours and up to 56 days after CSL730 administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) for CSL730 in serum samples |  | up to 56 days after CSL730 administration | 
| Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last) for CSL730 in serum samples |  | up to 56 days after CSL730 administration | 
| Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) for CSL730 in serum samples |  | up to 56 days after CSL730 administration | 
| Time of maximum concentration (Tmax) for CSL730 in serum samples |  | up to 56 days after CSL730 administration | 
| Terminal elimination half-life (T1/2) for CSL730 in serum samples |  | up to 56 days after CSL730 administration | 
| Apparent total systemic clearance (CL/F) for CSL730 in serum samples |  | up to 56 days after CSL730 administration | 
| Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples |  | up to 56 days after CSL730 administration | 
| Levels of anti-CSL730 antibodies detected in serum samples |  | Days 15, 29, and 56 |