Effects of CSL324 in the Lung After Segmental Challenge

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

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.

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.