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Completed

NCT Number: NCT04082754

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers

This is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild-to-moderate 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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Paraxel Berlin, Berlin, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects 18 to 65 years of age with diagnosis of mild-to-moderate asthma for Parts A and B. For part C healthy, male or female subjects 18 to 50 years

Exclusion criteria

  • Oral/parenteral corticosteroids or anti-interleukin-6 therapy within 6 months prior to screening, or any prohibited therapies prior to 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.

Treatment and study plan

Human beta common receptor antagonist monoclonal antibody

Biological

Human beta common receptor antagonist monoclonal antibody

Other names: CSL311

Placebo

Drug

0.9% sodium chloride, same volume and same duration as CSL311

Primary outcomes

  1. Percentage of subjects with treatment-emergent adverse events (TEAEs) in SC single dose, single ascending doses (SAD) and multiple ascending doses (MAD - SC and IV)

    Time frame: After infusion or injection, up to Day 85 for Cohorts A1 to A7, Day 57 for Cohort A8, Day 114 for Cohort B1 and Day 85 for Cohorts C1 to C3

  2. Percentage of subjects with related TEAEs in SC single dose, SAD and MAD (SC and IV)

    Time frame: After infusion or injection, up to Day 85 for Cohorts A1 to A7, Day 57 for Cohort A8, Day 114 for Cohort B1 and Day 85 for Cohorts C1 to C3

  3. Percentage of subjects with TEAEs by severity in SC single dose, SAD and MAD (SC and IV)

    Time frame: After infusion or injection, up to Day 85 for Cohorts A1 to A7, Day 57 for Cohort A8, Day 114 for Cohort B1 and Day 85 for Cohorts C1 to C3

    Severity of TEAEs defined as mild, moderate, or severe

Secondary outcomes

  1. Maximum plasma concentration (Cmax) of CSL311 in SAD

    Time frame: Up to 85 days after infusion

  2. Time to reach Cmax (tmax) of CSL311 in SAD

    Time frame: Up to 85 days 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 85 days 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 85 days after infusion

  5. Half-life (t½) of CSL311 in SAD

    Time frame: Up to 85 days after infusion

  6. Clearance (CL) of CSL311 in SAD

    Time frame: Up to 85 days after infusion

  7. Volume of distribution (Vd) of CSL311 in SAD

    Time frame: Up to 85 days 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 85 days after infusion

  9. Cmax/dose of CSL311 in SAD

    Time frame: Up to 85 days after infusion

  10. AUCtau for CSL311 in MAD (SC and IV) after first dose

    Time frame: Up to 15 days after infusion or injection

  11. AUCtau/dose for CSL311 in MAD (SC and IV) after first dose

    Time frame: Up to 15 days after infusion or injection

  12. Cmax of CSL311 in MAD (SC and IV) after first dose

    Time frame: Up to 15 days after infusion or injection

  13. Cmax/dose of CSL311 in MAD (SC and IV) after first dose

    Time frame: Up to 15 days after infusion or injection

    Dose-normalized maximum plasma concentration

  14. tmax of CSL311 in MAD (SC and IV) after first dose

    Time frame: Up to 15 days after infusion or injection

  15. Cmax of CSL311 in MAD (SC and IV) after last dose

    Time frame: Up to 85 days (SC) and 114 days (IV) after infusion or injection

  16. AUCtau for CSL311 in MAD (SC and IV) after last dose

    Time frame: Up to 85 days (SC) and 114 days (IV) after infusion or injection

  17. Cmax/dose of CSL311 in MAD (SC and IV) after last dose

    Time frame: Up to 85 days (SC) and 114 days (IV) after infusion or injection

  18. tmax of CSL311 in MAD (SC and IV) after last dose

    Time frame: Up to 85 days (SC) and 114 days (IV) after infusion or injection

  19. AUCtau/dose for CSL311 in MAD (SC and IV) after last dose

    Time frame: Up to 85 days (SC) and 114 days (IV) after infusion or injection

    Dose-normalized area under the concentration-time curve over a dosing interval

  20. Half-life (t½) of CSL311 in MAD (SC and IV) after last dose

    Time frame: Up to 85 days (SC) and 114 days (IV) after infusion or injection

  21. Clearance (CL) of CSL311 in MAD (IV) after last dose

    Time frame: Up to 114 days after infusion

  22. Apparent Clearance (CL/F) of CSL311 in MAD (SC) after last dose

    Time frame: Up to 85 days after injection

  23. Volume of distribution (Vd) of CSL311 in MAD (IV) after last dose

    Time frame: Up to 114 days after infusion

  24. Apparent volume of distribution during terminal phase (Vz/F) of CSL311 in MAD (SC) after last dose

    Time frame: Up to 85 days after injection

  25. Number of subjects with detectable anti-CSL311 antibodies in SAD and MAD (SC and IV)

    Time frame: After infusion or injection, up to 85 days for SAD, and up to 85 days for MAD (SC) and 114 days for MAD (IV)

  26. Percentage of subjects with TEAEs of Infections and Infestations in SAD and MAD (SC and IV) by treatment (CSL311 or placebo), by causality, and by CSL311 dose level

    Time frame: After infusion or injection, up to 85 days for SAD, and up to 85 days for MAD (SC) and 114 days for MAD (IV)

  27. Percentage of subjects with severe or life-threatening Neutropenia in SAD and MAD (SC and IV) by treatment (CSL311 or placebo), by causality, and by CSL311 dose level

    Time frame: After infusion or injection, up to 85 days for SAD, and up to 85 days for MAD (SC) and 114 days for MAD (IV)

  28. Percentage of subjects with TEAEs of Worsening Asthma in SAD and MAD (SC and IV) by treatment (CSL311 or placebo), by causality, and by CSL311 dose level

    Time frame: After infusion or injection, up to 85 days for SAD, and up to 85 days for MAD (SC) and 114 days for MAD (IV)

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Subjects With Mild-to-moderate Asthma and in Healthy Volunteers

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2019
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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