Healthy Volunteers

Effects of CSL324 in the Lung After Segmental Challenge

NCT05653713 | PHASE 1 | INTERVENTIONAL

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.

1 Sites

40 Participants

Recruiting

18 Years to 65 Years

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SUBMIT

Fraunhofer Institute for Toxicology and Experimental Medicine

Hannover,Germany,30625

Study Eligibility Criteria

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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov