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Trial record 1 of 1 for:    CSL311_1001
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A Clinical Study to Test the Safety, Exposure, and Markers of Efficacy of CSL311 in Patients With Mild Asthma

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ClinicalTrials.gov Identifier: NCT04082754
Recruitment Status : Not yet recruiting
First Posted : September 9, 2019
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Brief Summary:
This is a phase 1, first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild asthma. The primary objective of this study is to assess the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of CSL311.

Condition or disease Intervention/treatment Phase
Asthma Biological: Human beta common receptor antagonist monoclonal antibody Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-human, Single-center, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Ascending Dose Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL311 in Subjects With Mild Asthma
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: CSL311 Cohort A1 (SAD Dose 1)
Human beta common receptor antagonist monoclonal antibody administered intravenously at a Single Ascending Dose (SAD)
Biological: Human beta common receptor antagonist monoclonal antibody
Human beta common receptor antagonist monoclonal antibody administered intravenously
Other Name: CSL311

Experimental: CSL311 Cohort A2 (SAD Dose 2)
Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD
Biological: Human beta common receptor antagonist monoclonal antibody
Human beta common receptor antagonist monoclonal antibody administered intravenously
Other Name: CSL311

Experimental: CSL311 Cohort A3 (SAD Dose 3)
Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD
Biological: Human beta common receptor antagonist monoclonal antibody
Human beta common receptor antagonist monoclonal antibody administered intravenously
Other Name: CSL311

Experimental: CSL311 Cohort A4 (SAD Dose 4)
Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD
Biological: Human beta common receptor antagonist monoclonal antibody
Human beta common receptor antagonist monoclonal antibody administered intravenously
Other Name: CSL311

Experimental: CSL311 Cohort A5 (SAD Dose 5)
Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD
Biological: Human beta common receptor antagonist monoclonal antibody
Human beta common receptor antagonist monoclonal antibody administered intravenously
Other Name: CSL311

Experimental: CSL311 Cohort A6 (SAD Dose 6)
Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD
Biological: Human beta common receptor antagonist monoclonal antibody
Human beta common receptor antagonist monoclonal antibody administered intravenously
Other Name: CSL311

Experimental: CSL311 Cohort A7 (SAD Dose 7)
Human beta common receptor antagonist monoclonal antibody administered intravenously at a SAD
Biological: Human beta common receptor antagonist monoclonal antibody
Human beta common receptor antagonist monoclonal antibody administered intravenously
Other Name: CSL311

Experimental: CSL311 Cohort B1 (MAD Dose 1)
Human beta common receptor antagonist monoclonal antibody administered intravenously at a Multiple Ascending Dose (MAD)
Biological: Human beta common receptor antagonist monoclonal antibody
Human beta common receptor antagonist monoclonal antibody administered intravenously
Other Name: CSL311

Experimental: CSL311 Cohort B2 (MAD Dose 2)
Human beta common receptor antagonist monoclonal antibody administered intravenously at a MAD
Biological: Human beta common receptor antagonist monoclonal antibody
Human beta common receptor antagonist monoclonal antibody administered intravenously
Other Name: CSL311

Experimental: CSL311 Cohort B3 (MAD Dose 3)
Human beta common receptor antagonist monoclonal antibody administered intravenously at a MAD
Biological: Human beta common receptor antagonist monoclonal antibody
Human beta common receptor antagonist monoclonal antibody administered intravenously
Other Name: CSL311

Experimental: CSL311 Cohort B4 (MAD Dose 4)
Human beta common receptor antagonist monoclonal antibody administered intravenously at a MAD
Biological: Human beta common receptor antagonist monoclonal antibody
Human beta common receptor antagonist monoclonal antibody administered intravenously
Other Name: CSL311

Placebo Comparator: Placebo
0.9% sodium chloride solution administered intravenously
Drug: Placebo
0.9% sodium chloride, same volume and same duration as CSL311, administered intravenously




Primary Outcome Measures :
  1. Percentage of subjects with treatment-emergent adverse events (TEAEs) in single ascending doses (SAD) [ Time Frame: Up to 13 weeks after infusion ]
  2. Percentage of subjects with treatment-emergent adverse events (TEAEs) in multiple ascending doses (MAD) [ Time Frame: Up to 17 weeks after infusion ]
  3. Percentage of subjects with related TEAEs in SAD [ Time Frame: Up to 13 weeks after infusion ]
  4. Percentage of subjects with related TEAEs in MAD [ Time Frame: Up to 17 weeks after infusion ]
  5. Percentage of subjects with TEAEs by severity in SAD [ Time Frame: Up to 13 weeks after infusion ]
    Severity of TEAEs defined as mild, moderate, or severe

  6. Percentage of subjects with TEAEs by severity in MAD [ Time Frame: Up to 17 weeks after infusion ]
    Severity of TEAEs defined as mild, moderate, or severe


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of CSL311 in SAD [ Time Frame: Up to 13 weeks after infusion ]
  2. Time to reach Cmax (tmax) of CSL311 in SAD [ Time Frame: Up to 13 weeks after infusion ]
  3. Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL311 in SAD [ Time Frame: Up to 13 weeks after infusion ]
  4. Area under the concentration-time curve from time 0 extrapolated to infinite time (AUC0-inf) of CSL311 in SAD [ Time Frame: Up to 13 weeks after infusion ]
  5. Half-life (t½) of CSL311 in SAD [ Time Frame: Up to 13 weeks after infusion ]
  6. Clearance (CL) of CSL311 in SAD [ Time Frame: Up to 13 weeks after infusion ]
  7. Volume of distribution (Vd) of CSL311 in SAD [ Time Frame: Up to 13 weeks after infusion ]
  8. Area under the concentration-time curve from time 0 to the last measurable concentration per dose of CSL311 (AUC0-last/dose) in SAD [ Time Frame: Up to 13 weeks after infusion ]
  9. Cmax/dose of CSL311 in SAD [ Time Frame: Up to 13 weeks after infusion ]
  10. AUCtau for CSL311 in MAD after first dose [ Time Frame: Up to 15 days after infusion ]
  11. AUCtau/dose for CSL311 in MAD after first dose [ Time Frame: Up to 15 days after infusion ]
  12. Cmax/dose of CSL311 in MAD after first dose [ Time Frame: Up to 15 days after infusion ]
  13. Cmax/dose of CSL311 in MAD after first dose [ Time Frame: Up to 15 days after infusion ]
    Dose-normalized maximum plasma concentration

  14. tmax of CSL311 in MAD after first dose [ Time Frame: Up to 15 days after infusion ]
  15. Cmax of CSL311 in MAD after last dose [ Time Frame: Up to 13 weeks after infusion ]
  16. AUCtau for CSL311 in MAD after last dose [ Time Frame: Up to 13 weeks after infusion ]
  17. Cmax/dose of CSL311 in MAD after last dose [ Time Frame: Up to 13 weeks after infusion ]
  18. tmax of CSL311 in MAD after last dose [ Time Frame: Up to 13 weeks after infusion ]
  19. AUCtau/dose for CSL311 in MAD after last dose [ Time Frame: Up to 13 weeks after infusion ]
    Dose-normalized area under the concentration-time curve over a dosing interval

  20. Half-life (t½) of CSL311 in MAD after last dose [ Time Frame: Up to 13 weeks after infusion ]
  21. Clearance (CL) of CSL311 in MAD after last dose [ Time Frame: Up to 13 weeks after infusion ]
  22. Volume of distribution (Vd) of CSL311 in MAD after last dose [ Time Frame: Up to 13 weeks after infusion ]
  23. Number of subjects with detectable anti-CSL311 antibodies in SAD and MAD [ Time Frame: Up to 13 weeks after infusion for SAD and up to 17 after infusion weeks for MAD ]
  24. Percentage of subjects with TEAEs of Infections and Infestations in SAD and MAD by treatment (CSL311 or placebo), by causality, and by CSL311 dose level [ Time Frame: Up to 13 weeks after infusion for SAD and up to 17 after infusion weeks for MAD ]
  25. Percentage of subjects with severe or life-threatening Neutropenia in SAD and MAD by treatment (CSL311 or placebo), by causality, and by CSL311 dose level [ Time Frame: Up to 13 weeks after infusion for SAD and up to 17 weeks after infusion for MAD ]
  26. Percentage of subjects with TEAEs of Worsening Asthma in SAD and MAD by treatment (CSL311 or placebo), by causality, and by CSL311 dose level [ Time Frame: Up to 13 weeks after infusion for SAD and up to 17 weeks after infusion for MAD ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects 18 to 65 years of age with diagnosis of mild asthma

Exclusion Criteria:

  • Oral/parenteral corticosteroids, anti-interleukin-5 therapy, or live-attenuated vaccines within 6 months before screening.
  • History or presence of clinically significant hypertension or other significant cardiovascular abnormality.
  • Any clinically significant abnormality on electrocardiogram at screening.
  • Parasitic infestation within 6 months before screening, or travel or intention to travel to a country with a high prevalence of such infections within 1 year before screening or within 85 days after the last dose of CSL311.
  • Occurrence of asthma exacerbation and/or upper/lower respiratory tract infection, or any acute infection or disease within the last 6 weeks before screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082754


Contacts
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Contact: Trial Registration Coordinator 610-878-400 clinicaltrials@cslbehring.com

Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Director CSL Behring

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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT04082754     History of Changes
Other Study ID Numbers: CSL311_1001
2019-001135-32 ( EudraCT Number )
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents