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

Sponsor
CSL Behring (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04446000
Collaborator
(none)
60
Enrollment
1
Location
11
Arms
26.3
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CSL730
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 23, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. Percent of subjects with TEAEs overall, by causality, and by severity [Within 96 hours and up to 56 days after CSL730 administration]

    3. 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]

    4. 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

    1. Maximum concentration (Cmax) for CSL730 in serum samples [up to 56 days after CSL730 administration]

    2. 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]

    3. 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]

    4. Time of maximum concentration (Tmax) for CSL730 in serum samples [up to 56 days after CSL730 administration]

    5. Terminal elimination half-life (T1/2) for CSL730 in serum samples [up to 56 days after CSL730 administration]

    6. Apparent total systemic clearance (CL/F) for CSL730 in serum samples [up to 56 days after CSL730 administration]

    7. Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples [up to 56 days after CSL730 administration]

    8. Levels of anti-CSL730 antibodies detected in serum samples [Days 15, 29, and 56]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital Harrow United Kingdom HA1 3UJ

    Sponsors and Collaborators

    • CSL Behring

    Investigators

    • Study Director: Study Director, CSL Behring

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CSL Behring
    ClinicalTrials.gov Identifier:
    NCT04446000
    Other Study ID Numbers:
    • CSL730_1002
    • 2019-001940-23
    First Posted:
    Jun 24, 2020
    Last Update Posted:
    Jun 10, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Autoimmune Diseases

    Study Results

    No Results Posted as of Jun 10, 2022