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CompletedNCT04643587Updated Dec 15, 2023

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

A Phase 1 interventional study of CSL787 and Placebo in Noncystic Fibrosis Bronchiectasis (NCFB), sponsored by CSL Behring. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-15.

Sponsored by CSL Behring (part of CSL Limited) · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Noncystic Fibrosis Bronchiectasis (NCFB)
03

In context

Lead sponsor

CSL Behring is the lead sponsor of 145 studies on the registry; 17 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.

First submitted after CSL Behring became part of CSL Limited.

Browse CSL Behring studies →All CSL Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    CSL787 (SAD dose 1)

    Inhalation by mouth of a nebulized aerosol in healthy subjects

    Biological: CSL787

  • Experimental
    CSL787 (SAD dose 2)

    Inhalation by mouth of a nebulized aerosol in healthy subjects

    Biological: CSL787

  • Experimental
    CSL787 (SAD dose 3)

    Inhalation by mouth of a nebulized aerosol in healthy subjects

    Biological: CSL787

  • Experimental
    CSL787 (SAD dose 4)

    Inhalation by mouth of a nebulized aerosol in healthy subjects

    Biological: CSL787

  • Experimental
    CSL787 (MAD dose 1)

    Inhalation by mouth of a nebulized aerosol in NCFB subjects

    Biological: CSL787

  • Experimental
    CSL787 (MAD dose 2)

    Inhalation by mouth of a nebulized aerosol in NCFB subjects

    Biological: CSL787

  • Experimental
    CSL787 (MAD dose 3)

    Inhalation by mouth of a nebulized aerosol in NCFB subjects

    Biological: CSL787

  • Placebo comparator
    Placebo

    Inhalation by mouth of a nebulized aerosol

    Drug: Placebo

Interventions

  • BiologicalCSL787

    Human plasma-derived polyvalent immunoglobulin G (IgG) administered via inhalation of an aerosol produced using a nebulizer

  • DrugPlacebo

    Normal saline (0.9% NaCl)

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

3 sites
  • IKF Pneumologie Institute
    Frankfurt, Germany
  • Medicines Evaluation Unit (MEU)
    Manchester, England M23 9QZ, United Kingdom
  • Celerion
    Belfast, Northern Ireland BT9 6AD, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — 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 information: Study protocol, Statistical analysis plan

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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04643587
Lead sponsor
CSL Behring
Responsible party
Sponsor
First posted
Nov 25, 2020
Start date
Dec 7, 2020
Primary completion
Mar 12, 2023
Completion
Mar 12, 2023
Last update
Dec 15, 2023

Study contacts

Study Director
study director · CSL Behring

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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