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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05653713
Other study ID # CSL324_1004
Secondary ID 2022-002404-20
Status Completed
Phase Phase 1
First received
Last updated
Start date December 20, 2022
Est. completion date July 21, 2023

Study information

Verified date November 2023
Source CSL Behring
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a phase 1b, randomized, double-blind, placebo-controlled study in healthy volunteers to investigate the antiinflammatory effect of pretreatment with CSL324 on response to a lipopolysaccharide (LPS) endotoxin challenge in a single lung segment. Saline will be instilled into a segment in the contralateral lung for the purpose of comparison.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 21, 2023
Est. primary completion date July 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Male or female volunteer. - Between the ages of = 18 and = 65 years. - Body mass index within the range of 18 to 32 kg/m2 - Female of nonchildbearing potential or of childbearing potential and willing to use a highly effective method of contraception (in addition to male partner condom with or without spermicide) - Nonsmoker or an ex-smoker who has stopped smoking (including e-cigarettes or vaping devices) for > 1 year with a smoking history of < 10 pack-years. Exclusion Criteria: - Any clinically significant abnormalities in physical examination findings, electrocardiogram (ECG) readings, safety laboratory test results, or ANC < 2.0 × 109 cells/L. - History of myeloproliferative or lymphoproliferative disease. - Current or previous history of any immunosuppressive condition. - Currently receiving any immunosuppressive or immunomodulatory therapy, or history of undergoing such therapy.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CSL324
Single intravenous (IV) dose of CSL324
Placebo
IV dose of 0.9% saline

Locations

Country Name City State
Germany Fraunhofer Institute for Toxicology and Experimental Medicine Hannover

Sponsors (1)

Lead Sponsor Collaborator
CSL Behring

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent reduction in mean absolute neutrophil cell counts in bronchoalveolar lavage fluid (BALF) between CSL324 and placebo Obtained at 24 hours after the segmental lipopolysaccharide (LPS) challenge with endotoxin in the lung
Secondary Percent reduction in the mean change in biomarkers of neutrophil activation in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo Biomarkers are (neutrophil elastase [NE], alpha [a] 1 antitrypsin [AAT) complex, and myeloperoxidase [MPO]) in BALF Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Secondary Percent reduction in the mean change in total protein in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Secondary Percent reduction in the mean change in concentrations of von Willebrand factor (vWF) in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Secondary Percent reduction in the mean change in concentrations of surfactant protein D (SP D) in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Secondary Percent reduction in the mean change in concentrations of sRAGE in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Secondary Percent reduction in the mean change in concentrations of G CSF in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Secondary Percent reduction in the mean change in concentrations of VEGF A in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Secondary Serum concentration of CSL324 Up to 6 days after CSL324 administration
Secondary Number of subjects with antidrug antibodies (ADAs) to CSL324 in serum Prior to and up to 6 days after CSL324 and placebo administration
Secondary Number and percentage of subjects with treatment-emergent adverse events (TEAEs) by treatment group Up to 32 days after CSL324 and placebo administration
Secondary Maximum plasma concentration (Cmax) Prior to and up to 6 days after CSL324 administration
Secondary Time to reach Cmax (Tmax) Prior to and up to 6 days after CSL324 administration
Secondary Area under the plasma concentration-time curve from time 0 to 120 hours (AUC0-120h) Time 0 to 120 hours after CSL324 administration
Secondary Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-last) Time 0 and up to 6 days after CSL324 administration
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