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

Primary Purpose

Immune Complex-mediated Autoimmune Diseases

Status

Terminated

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

CSL730

Placebo

About this trial

This is an interventional treatment trial for Immune Complex-mediated Autoimmune Diseases

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Placebo Comparator

Arm Label

CSL730 (dose 1 with premedication)

CSL730 (dose 2 with premedication)

CSL730 (dose 3 with premedication)

CSL730 (dose 1 without premedication)

CSL730 (dose 2 without premedication)

CSL730 (dose 3 without premedication)

CSL730 (dose 4 without premedication)

CSL730 (dose 5 without premedication)

CSL730 (dose 6 without premedication)

CSL730 (dose 7 without premedication)

Placebo

Arm Description

administered as a single dose by subcutaneous (SC) injection or by SC infusion

administered as a single dose by SC injection or by SC infusion

A solution matching the excipient profile of CSL730 without the active substance administered as a single dose by SC injection or by SC infusion

Outcomes

Primary Outcome Measures

Number of subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity

Percent of subjects with TEAEs overall, by causality, and by severity

Number of subjects with localized administration site AEs overall, by causality, and by severity

Percent of subjects with localized administration site AEs overall, by causality, and by severity

Secondary Outcome Measures

Maximum concentration (Cmax) for CSL730 in serum samples

Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last) for CSL730 in serum samples

Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) for CSL730 in serum samples

Time of maximum concentration (Tmax) for CSL730 in serum samples

Terminal elimination half-life (T1/2) for CSL730 in serum samples

Apparent total systemic clearance (CL/F) for CSL730 in serum samples

Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples

Levels of anti-CSL730 antibodies detected in serum samples

Full Information

NCT ID

NCT04446000

First Posted

June 22, 2020

Last Updated

August 11, 2023

Sponsor

CSL Behring

1. Study Identification

Unique Protocol Identification Number

NCT04446000

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Terminated

Why Stopped

Lack of clinical viability

Study Start Date

September 23, 2020 (Actual)

Primary Completion Date

March 28, 2023 (Actual)

Study Completion Date

March 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSL Behring

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune Complex-mediated Autoimmune Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CSL730 (dose 1 with premedication)

Arm Type

Experimental

Arm Description

administered as a single dose by subcutaneous (SC) injection or by SC infusion

Arm Title

CSL730 (dose 2 with premedication)

Arm Type

Experimental

Arm Description

administered as a single dose by SC injection or by SC infusion

Arm Title

CSL730 (dose 3 with premedication)

Arm Type

Experimental

Arm Description

administered as a single dose by SC injection or by SC infusion

Arm Title

CSL730 (dose 1 without premedication)

Arm Type

Experimental

Arm Description

administered as a single dose by SC injection or by SC infusion

Arm Title

CSL730 (dose 2 without premedication)

Arm Type

Experimental

Arm Description

administered as a single dose by SC injection or by SC infusion

Arm Title

CSL730 (dose 3 without premedication)

Arm Type

Experimental

Arm Description

administered as a single dose by SC injection or by SC infusion

Arm Title

CSL730 (dose 4 without premedication)

Arm Type

Experimental

Arm Description

administered as a single dose by SC injection or by SC infusion

Arm Title

CSL730 (dose 5 without premedication)

Arm Type

Experimental

Arm Description

administered as a single dose by SC injection or by SC infusion

Arm Title

CSL730 (dose 6 without premedication)

Arm Type

Experimental

Arm Description

administered as a single dose by SC injection or by SC infusion

Arm Title

CSL730 (dose 7 without premedication)

Arm Type

Experimental

Arm Description

administered as a single dose by SC injection or by SC infusion

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

A solution matching the excipient profile of CSL730 without the active substance administered as a single dose by SC injection or by SC infusion

Intervention Type

Biological

Intervention Name(s)

CSL730

Other Intervention Name(s)

Recombinant trivalent human IgG1 Fc multimer

Intervention Description

solution for injection and infusion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

A solution matching the excipient profile of CSL730 without the active substance

Primary Outcome Measure Information:

Title

Number of subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity

Time Frame

Within 96 hours and up to 56 days after CSL730 administration

Title

Percent of subjects with TEAEs overall, by causality, and by severity

Time Frame

Within 96 hours and up to 56 days after CSL730 administration

Title

Number of subjects with localized administration site AEs overall, by causality, and by severity

Time Frame

Within 96 hours and up to 56 days after CSL730 administration

Title

Percent of subjects with localized administration site AEs overall, by causality, and by severity

Time Frame

Within 96 hours and up to 56 days after CSL730 administration

Secondary Outcome Measure Information:

Title

Maximum concentration (Cmax) for CSL730 in serum samples

Time Frame

up to 56 days after CSL730 administration

Title

Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last) for CSL730 in serum samples

Time Frame

up to 56 days after CSL730 administration

Title

Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) for CSL730 in serum samples

Time Frame

up to 56 days after CSL730 administration

Title

Time of maximum concentration (Tmax) for CSL730 in serum samples

Time Frame

up to 56 days after CSL730 administration

Title

Terminal elimination half-life (T1/2) for CSL730 in serum samples

Time Frame

up to 56 days after CSL730 administration

Title

Apparent total systemic clearance (CL/F) for CSL730 in serum samples

Time Frame

up to 56 days after CSL730 administration

Title

Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples

Time Frame

up to 56 days after CSL730 administration

Title

Levels of anti-CSL730 antibodies detected in serum samples

Time Frame

Days 15, 29, and 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

CSL Behring

Official's Role

Study Director

Facility Information:

Facility Name

PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital

City

Harrow

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

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

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