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

NCT ID: NCT04446000

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-23

Study Completion Date

2023-03-28

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.

Detailed Description

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Conditions

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Immune Complex-mediated Autoimmune Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CSL730 (dose 1 with premedication)

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

Group Type EXPERIMENTAL

CSL730

Intervention Type BIOLOGICAL

solution for injection and infusion

CSL730 (dose 2 with premedication)

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

Group Type EXPERIMENTAL

CSL730

Intervention Type BIOLOGICAL

solution for injection and infusion

CSL730 (dose 3 with premedication)

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

Group Type EXPERIMENTAL

CSL730

Intervention Type BIOLOGICAL

solution for injection and infusion

CSL730 (dose 1 without premedication)

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

Group Type EXPERIMENTAL

CSL730

Intervention Type BIOLOGICAL

solution for injection and infusion

CSL730 (dose 2 without premedication)

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

Group Type EXPERIMENTAL

CSL730

Intervention Type BIOLOGICAL

solution for injection and infusion

CSL730 (dose 3 without premedication)

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

Group Type EXPERIMENTAL

CSL730

Intervention Type BIOLOGICAL

solution for injection and infusion

CSL730 (dose 4 without premedication)

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

Group Type EXPERIMENTAL

CSL730

Intervention Type BIOLOGICAL

solution for injection and infusion

CSL730 (dose 5 without premedication)

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

Group Type EXPERIMENTAL

CSL730

Intervention Type BIOLOGICAL

solution for injection and infusion

CSL730 (dose 6 without premedication)

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

Group Type EXPERIMENTAL

CSL730

Intervention Type BIOLOGICAL

solution for injection and infusion

CSL730 (dose 7 without premedication)

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

Group Type EXPERIMENTAL

CSL730

Intervention Type BIOLOGICAL

solution for injection and infusion

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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CSL730

solution for injection and infusion

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Recombinant trivalent human IgG1 Fc multimer

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

CSL Behring

Locations

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

Harrow, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2019-001940-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSL730_1002

Identifier Type: -

Identifier Source: org_study_id