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Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04643587
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : December 22, 2022
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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Brief Summary:
This study is a prospective, multicenter, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and exploratory efficacy of nebulized CSL787 after administrations of single (SAD) ascending doses in healthy subjects and multiple (MAD) ascending doses in subjects with NCFB.

Condition or disease Intervention/treatment Phase
Noncystic Fibrosis Bronchiectasis (NCFB) Biological: CSL787 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of Nebulized CSL787 in Healthy Subjects and Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB)
Actual Study Start Date : December 7, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: CSL787 (SAD dose 1)
Inhalation by mouth of a nebulized aerosol in healthy subjects
 Biological: CSL787
Human plasma-derived polyvalent immunoglobulin G (IgG) administered via inhalation of an aerosol produced using a nebulizer
Experimental: CSL787 (SAD dose 2)
Inhalation by mouth of a nebulized aerosol in healthy subjects
 Biological: CSL787
Human plasma-derived polyvalent immunoglobulin G (IgG) administered via inhalation of an aerosol produced using a nebulizer
Experimental: CSL787 (SAD dose 3)
Inhalation by mouth of a nebulized aerosol in healthy subjects
 Biological: CSL787
Human plasma-derived polyvalent immunoglobulin G (IgG) administered via inhalation of an aerosol produced using a nebulizer
Experimental: CSL787 (SAD dose 4)
Inhalation by mouth of a nebulized aerosol in healthy subjects
 Biological: CSL787
Human plasma-derived polyvalent immunoglobulin G (IgG) administered via inhalation of an aerosol produced using a nebulizer
Experimental: CSL787 (MAD dose 1)
Inhalation by mouth of a nebulized aerosol in NCFB subjects
 Biological: CSL787
Human plasma-derived polyvalent immunoglobulin G (IgG) administered via inhalation of an aerosol produced using a nebulizer
Experimental: CSL787 (MAD dose 2)
Inhalation by mouth of a nebulized aerosol in NCFB subjects
 Biological: CSL787
Human plasma-derived polyvalent immunoglobulin G (IgG) administered via inhalation of an aerosol produced using a nebulizer
Experimental: CSL787 (MAD dose 3)
Inhalation by mouth of a nebulized aerosol in NCFB subjects
 Biological: CSL787
Human plasma-derived polyvalent immunoglobulin G (IgG) administered via inhalation of an aerosol produced using a nebulizer
Placebo Comparator: Placebo
Inhalation by mouth of a nebulized aerosol
 Drug: Placebo
Normal saline (0.9% NaCl)


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with treatment emergent adverse events (TEAEs) - overall, severity and causality [ Time Frame: Up to 8 days (healthy volunteers); Up to 21 days (NCFB patients) ]
  2. Percent of subjects with TEAEs - overall, severity and causality [ Time Frame: Up to 8 days (healthy volunteers); Up to 21 days (NCFB patients) ]

Secondary Outcome Measures :
  1. Maximum concentration (Cmax) of CSL787 in sputum and serum in healthy subjects [ Time Frame: Up to 8 days from inhalation ]
  2. Time of maximum concentration (Tmax) of CSL787 in sputum and serum in healthy subjects [ Time Frame: Up to 8 days from inhalation ]
  3. Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) of CSL787 in sputum and serum in healthy subjects [ Time Frame: Up to 8 days from inhalation ]
  4. Area under the concentration-time curve from time 0 to last quantifiable time point (AUC0-last) of CSL787 in sputum and serum in healthy subjects [ Time Frame: Up to 8 days from inhalation ]
  5. Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of CSL787 in sputum and serum in healthy subjects [ Time Frame: Up to 8 days from inhalation ]
  6. Apparent total clearance of the drug (CL/F) of CSL787 in sputum and serum in healthy subjects [ Time Frame: Up to 8 days from inhalation ]
  7. Apparent volume of distribution during the elimination phase (V/F) of CSL787 in sputum and serum in healthy subjects [ Time Frame: Up to 8 days from inhalation ]
  8. Terminal elimination half-life (T1/2) of CSL787 in sputum and serum in healthy subjects [ Time Frame: Up to 8 days from inhalation ]
  9. Cmax of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 1, after dosing ]
  10. Tmax of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 1, after dosing ]
  11. Ctrough of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 1, after dosing ]
  12. AUCtau of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 1, after dosing ]
  13. Cmax of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 14, after last dose ]
  14. Tmax of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 14, after last dose ]
  15. Ctrough of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 14, after last dose ]
  16. AUCtau of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 14, after last dose ]
  17. T1/2 of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 14, after last dose ]
  18. CL/F of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 14, after last dose ]
  19. V/F of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 14, after last dose ]
  20. Accumulation Ratio (AR) for Cmax of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 14, after last dose ]
  21. AR for Ctrough of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 14, after last dose ]
  22. AR for AUCtau of CSL787 in sputum and serum of NCFB subjects [ Time Frame: On Day 14, after last dose ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, aged ≥ 18 years at the time of providing written informed consent

For Part A (SAD) Only:

  • Healthy and free of medical conditions that could in the opinion of the investigator affect's the subject's participation in the study or the interpretation of results.

For Part B (MAD) Only:

  • Diagnosis of NCFB made by a respiratory physician, confirmed per CT showing bronchial wall dilatation with or without bronchial wall thickening, with a FEV1 ≥ 40% of the predicted value regarding age, height, gender, ethnicity, and FEV1 ≥ 1 L (pre-bronchodilator values) at the Screening Visit.
  • No antibiotic use within 1 month before the Screening Visit.
  • Presence of one or more of the following bacteria (H. influenzae, P. aeruginosa, M. catarrhalis, S. pneumoniae, members of Enterobacterales family or S. aureus) in the sputum culture at the Screening Visit.
  • Has been fully vaccinated against COVID-19 (as per country recommendations) at least 7 days prior to Day 1

Exclusion Criteria:

  • Evidence of a clinically significant medical condition, disorder, or disease, including but not limited to any of the following: hepatic (hepatitis, cirrhosis); biliary; renal; cardiac; bronchopulmonary; vascular; hematologic; gastrointestinal; allergy; endocrine / metabolic (diabetes, thyroid disorders, adrenal disease); neurologic; psychiatric; immunodeficiency; cancer.
  • History of chronic respiratory disease (eg, COPD or bronchiectasis) or current asthma with regular treatment including occasional use of an inhaler for exercise induced asthma.
  • Current moderate-severe allergic disease (eg, allergic rhinitis) with regular treatment.
  • Diagnosis of cystic fibrosis, mycobacterial disease, connective tissue disease, or alpha-1 antitrypsin deficiency as underlying disease for bronchiectasis.
  • Oral/parenteral corticosteroid 28 days before the Screening Visit until EOS Visit. Use of long acting bronchodilators (long acting muscarinic antagonists (LAMA) and / or long acting beta2 agonists (LABA) and/or inhaled corticosteroids that have been at a stable dose for at least 3 months before the Screening Visit is permitted; inhalation with hypertonic saline solution is permitted up to and including Day -1.
  • Any systemic or inhaled antibiotic for acute pulmonary exacerbation within 1 month before the Screening Visit until EOS Visit.
Contacts and Locations
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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): NCT04643587


Contacts
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Contact: Trial Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com

Locations
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Germany
IKF Pneumologie Institute Recruiting
Frankfurt, Germany
United Kingdom
Medicines Evaluation Unit (MEU) Recruiting
Manchester, England, United Kingdom, M23 9QZ
Celerion Recruiting
Belfast, Northern Ireland, United Kingdom, BT9 6AD
Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Director CSL Behring
More Information
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT04643587    
Other Study ID Numbers: CSL787_1001
2020-002684-66 ( EudraCT Number )
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022
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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Bronchiectasis
Fibrosis
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases