NCT04643587

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2020

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

December 7, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2023

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

2.3 years

First QC Date

November 19, 2020

Last Update Submit

December 14, 2023

Conditions

Noncystic Fibrosis Bronchiectasis (NCFB)

Outcome Measures

Primary Outcomes (2)

  • Number of subjects with treatment emergent adverse events (TEAEs) - overall, severity and causality

    Up to 8 days (healthy volunteers); Up to 21 days (NCFB patients)

  • Percent of subjects with TEAEs - overall, severity and causality

    Up to 8 days (healthy volunteers); Up to 21 days (NCFB patients)

Secondary Outcomes (22)

  • Maximum concentration (Cmax) of CSL787 in sputum and serum in healthy subjects

    Up to 8 days from inhalation

  • Time of maximum concentration (Tmax) of CSL787 in sputum and serum in healthy subjects

    Up to 8 days from inhalation

  • Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) of CSL787 in sputum and serum in healthy subjects

    Up to 8 days from inhalation

  • 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

    Up to 8 days from inhalation

  • Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of CSL787 in sputum and serum in healthy subjects

    Up to 8 days from inhalation

  • +17 more secondary outcomes

Study Arms (8)

CSL787 (SAD dose 1)

EXPERIMENTAL

Inhalation by mouth of a nebulized aerosol in healthy subjects

Biological: CSL787

CSL787 (SAD dose 2)

EXPERIMENTAL

Inhalation by mouth of a nebulized aerosol in healthy subjects

Biological: CSL787

CSL787 (SAD dose 3)

EXPERIMENTAL

Inhalation by mouth of a nebulized aerosol in healthy subjects

Biological: CSL787

CSL787 (SAD dose 4)

EXPERIMENTAL

Inhalation by mouth of a nebulized aerosol in healthy subjects

Biological: CSL787

CSL787 (MAD dose 1)

EXPERIMENTAL

Inhalation by mouth of a nebulized aerosol in NCFB subjects

Biological: CSL787

CSL787 (MAD dose 2)

EXPERIMENTAL

Inhalation by mouth of a nebulized aerosol in NCFB subjects

Biological: CSL787

CSL787 (MAD dose 3)

EXPERIMENTAL

Inhalation by mouth of a nebulized aerosol in NCFB subjects

Biological: CSL787

Placebo

PLACEBO COMPARATOR

Inhalation by mouth of a nebulized aerosol

Drug: Placebo

Interventions

CSL787BIOLOGICAL

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

CSL787 (MAD dose 1)CSL787 (MAD dose 2)CSL787 (MAD dose 3)CSL787 (SAD dose 1)CSL787 (SAD dose 2)CSL787 (SAD dose 3)CSL787 (SAD dose 4)
PlaceboDRUG

Normal saline (0.9% NaCl)

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

IKF Pneumologie Institute

Frankfurt, Germany

Location

Medicines Evaluation Unit (MEU)

Manchester, England, M23 9QZ, United Kingdom

Location

Celerion

Belfast, Northern Ireland, BT9 6AD, United Kingdom

Location

Study Officials

  • Study Director

    CSL Behring

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2020

First Posted

November 25, 2020

Study Start

December 7, 2020

Primary Completion

March 12, 2023

Study Completion

March 12, 2023

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, 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.

Locations

GB(2)DE(1)