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

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

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.

Study Overview

• Status: Terminated
• Conditions: Immune Complex-mediated Autoimmune Diseases
• Intervention / Treatment: Biological: CSL730; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

11

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: CSL Behring
• Investigators: Study Director: Study Director, CSL Behring

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: CSL730_1002; 2019-001940-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

• IPD Sharing Time Frame: IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.

IPD Sharing Access Criteria

Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.

An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.

The requesting party must execute an appropriate data sharing agreement before IPD will be made available.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No