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Recruiting
NCT05653713
Effects of CSL324 in the Lung After Segmental Challenge
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 40
Sponsor: CSL Behring
Location: Germany
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.
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/m2Female 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.
Source: ClinicalTrials.gov (NCT05653713). StuddyBuddy aggregates publicly available trial information.