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Assessing the Safety and Tolerability of CSL730 in Healthy Caucasian and Japanese Adults

Sponsor
CSL Behring (Industry)
Overall Status
Terminated
CT.gov ID
NCT03375606
Collaborator
(none)
26
Enrollment
2
Locations
2
Arms
29.4
Actual Duration (Months)
13
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the safety and tolerability of ascending doses of CSL730 after a single intravenous (IV) infusion in healthy Caucasian and Japanese subjects

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

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous CSL730 in Healthy Caucasian and Japanese Subjects
Actual Study Start Date :
Jan 10, 2018
Actual Primary Completion Date :
Jun 22, 2020
Actual Study Completion Date :
Jun 22, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: CSL730

Biological: CSL730
Solution for IV infusion
Other Names:
  • Recombinant trivalent human IgG1 Fc multimer

    		•
    Placebo Comparator: Placebo

    Other: Placebo
    Saline solution for IV infusion

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of subjects with adverse events overall, and by causality and severity [Up to 8 weeks after infusion]

    Secondary Outcome Measures

    1. Maximum observed concentration (Cmax) of CSL730 in serum [Before study drug infusion and up to 56 days after the start of the infusion.]

    2. Area under the concentration-time curve from time 0 to the last collection time (AUC0-last) of CSL730 in serum [Before study drug infusion and up to 56 days after the start of the infusion.]

    3. Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL730 in serum [Before study drug infusion and up to 56 days after the start of the infusion.]

    4. Time of maximum observed concentration (Tmax) of CSL730 in serum [Before study drug infusion and up to 56 days after the start of the infusion.]

    5. Terminal elimination half-life (T1/2) of CSL730 in serum [Before study drug infusion and up to 56 days after the start of the infusion.]

    6. Total systemic clearance (CL) of CSL730 in serum [Before study drug infusion and up to 56 days after the start of the infusion.]

    7. Volume of distribution during the elimination phase (Vz) of CSL730 in serum [Before study drug infusion and up to 56 days after the start of the infusion.]

    8. Number of subjects with anti-CSL730 antibodies in serum [Before study drug infusion and up to 56 days after the start of the infusion.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy males or females (postmenopausal or surgically sterile only) aged ≥ 20 to ≤ 55 years and of Caucasian or Japanese descent
    Exclusion Criteria:

    • Evidence of a clinically significant medical condition, disorder, or disease as judged by Investigator and / or study Medical Monitor.

    • History of asthma (with the exception of childhood asthma that has resolved), chronic obstructive pulmonary disease, or recurrent or current respiratory infections; splenectomy; or recurrent or current gastrointestinal infections.

    • Evidence of active or latent tuberculosis.

    • Known or suspected hypersensitivity to the IP, to any excipients of the IP, humanized monoclonal antibodies, or Fc fusion protein therapeutics.

    • History, or current diagnosis, of substance use disorder.

    • Any abnormal clinical laboratory values deemed clinically significant by the Investigator and / or study Medical Monitor.

    • Positive serology test result for human immunodeficiency virus antibody, hepatitis virus B surface antigen or hepatitis virus C antibody at Screening.

    • Donation or loss of ≥ 480 mL of whole blood within 2 months or donation of plasma within 14 days before Day -1.

    • Plans to participate in another investigational drug study while enrolled in this study, or has participated in any other investigational drug study in which they were known to have been administered a monoclonal antibody or biological IP within 4 months, any other investigational drug study within 60 days or > 3 investigational drug studies within 12 months before IP administration.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PRA Health Sciences Groningen Netherlands
    2 Hammersmith Medicines Research London United Kingdom

    Sponsors and Collaborators

    • CSL Behring

    Investigators

    • Study Director: Program Director, CSL Behring

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CSL Behring
    ClinicalTrials.gov Identifier:
    NCT03375606
    Other Study ID Numbers:
    • CSL730_1001
    • 2017-003478-15
    First Posted:
    Dec 18, 2017
    Last Update Posted:
    Jun 3, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 3, 2021