Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002404-20 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSL324 | Experimental | Intravenous (IV) dose of CSL324 |
|
| Placebo | Placebo Comparator | IV dose of 0.9% saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL324 | Drug | Single intravenous (IV) dose of CSL324 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 [α] 1 antitrypsin [AAT) complex, and myeloperoxidase [MPO]) in BALF](streamdown:incomplete-link) | Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fraunhofer Institute for Toxicology and Experimental Medicine | Hanover | 30625 | Germany |
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
Proposed research should seek to answer a previously unanswered important medical or scientific question.
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.
Not provided
Not provided
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | IV dose of 0.9% saline |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Serum concentration of CSL324 | Up to 6 days after CSL324 administration |
| Number of subjects with antidrug antibodies (ADAs) to CSL324 in serum | Prior to and up to 6 days after CSL324 and placebo administration |
| Number and percentage of subjects with treatment-emergent adverse events (TEAEs) by treatment group | Up to 32 days after CSL324 and placebo administration |
| Maximum plasma concentration (Cmax) | Prior to and up to 6 days after CSL324 administration |
| Time to reach Cmax (Tmax) | Prior to and up to 6 days after CSL324 administration |
| Area under the plasma concentration-time curve from time 0 to 120 hours (AUC0-120h) | Time 0 to 120 hours after CSL324 administration |
| 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 |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |