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

NCT ID: NCT04643587

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-07

Study Completion Date

2023-03-12

Brief Summary

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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.

Detailed Description

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Conditions

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Noncystic Fibrosis Bronchiectasis (NCFB)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CSL787 (SAD dose 1)

Inhalation by mouth of a nebulized aerosol in healthy subjects

Group Type EXPERIMENTAL

CSL787

Intervention Type BIOLOGICAL

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

CSL787 (SAD dose 2)

Inhalation by mouth of a nebulized aerosol in healthy subjects

Group Type EXPERIMENTAL

CSL787

Intervention Type BIOLOGICAL

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

CSL787 (SAD dose 3)

Inhalation by mouth of a nebulized aerosol in healthy subjects

Group Type EXPERIMENTAL

CSL787

Intervention Type BIOLOGICAL

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

CSL787 (SAD dose 4)

Inhalation by mouth of a nebulized aerosol in healthy subjects

Group Type EXPERIMENTAL

CSL787

Intervention Type BIOLOGICAL

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

CSL787 (MAD dose 1)

Inhalation by mouth of a nebulized aerosol in NCFB subjects

Group Type EXPERIMENTAL

CSL787

Intervention Type BIOLOGICAL

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

CSL787 (MAD dose 2)

Inhalation by mouth of a nebulized aerosol in NCFB subjects

Group Type EXPERIMENTAL

CSL787

Intervention Type BIOLOGICAL

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

CSL787 (MAD dose 3)

Inhalation by mouth of a nebulized aerosol in NCFB subjects

Group Type EXPERIMENTAL

CSL787

Intervention Type BIOLOGICAL

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

Placebo

Inhalation by mouth of a nebulized aerosol

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal saline (0.9% NaCl)

Interventions

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CSL787

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

Intervention Type BIOLOGICAL

Placebo

Normal saline (0.9% NaCl)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

CSL Behring

Locations

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IKF Pneumologie Institute

Frankfurt, , Germany

Site Status

Medicines Evaluation Unit (MEU)

Manchester, England, United Kingdom

Site Status

Celerion

Belfast, Northern Ireland, United Kingdom

Site Status

Countries

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Germany United Kingdom

Other Identifiers

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2020-002684-66

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSL787_1001

Identifier Type: -

Identifier Source: org_study_id