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Completed

NCT Number: NCT05653713

Effects of CSL324 in the Lung After Segmental Challenge

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fraunhofer Institute for Toxicology and Experimental Medicine

Hanover, 30625, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CSL324

Drug

Single intravenous (IV) dose of CSL324

Other names: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody (mAb)

Placebo

Drug

IV dose of 0.9% saline

Primary outcomes

  1. Percent reduction in mean absolute neutrophil cell counts in bronchoalveolar lavage fluid (BALF) between CSL324 and placebo

    Time frame: Obtained at 24 hours after the segmental lipopolysaccharide (LPS) challenge with endotoxin in the lung

Secondary outcomes

  1. 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

    Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung

    Biomarkers are (neutrophil elastase [NE], alpha [α] 1 antitrypsin [AAT) complex, and myeloperoxidase [MPO]) in BALF

  2. 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

    Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung

  3. 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

    Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung

  4. 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

    Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung

  5. 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

    Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung

  6. 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

    Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung

  7. 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

    Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung

  8. Serum concentration of CSL324

    Time frame: Up to 6 days after CSL324 administration

  9. Number of subjects with antidrug antibodies (ADAs) to CSL324 in serum

    Time frame: Prior to and up to 6 days after CSL324 and placebo administration

  10. Number and percentage of subjects with treatment-emergent adverse events (TEAEs) by treatment group

    Time frame: Up to 32 days after CSL324 and placebo administration

  11. Maximum plasma concentration (Cmax)

    Time frame: Prior to and up to 6 days after CSL324 administration

  12. Time to reach Cmax (Tmax)

    Time frame: Prior to and up to 6 days after CSL324 administration

  13. Area under the plasma concentration-time curve from time 0 to 120 hours (AUC0-120h)

    Time frame: Time 0 to 120 hours after CSL324 administration

  14. Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-last)

    Time frame: Time 0 and up to 6 days after CSL324 administration

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

A Phase 1b, Randomized, Double-blind, Placebo-controlled Study in Healthy Volunteers to Investigate the Effects of CSL324 in the Lung After Segmental Challenge With Endotoxin

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 16, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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