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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05653713). StuddyBuddy aggregates publicly available trial information.