Effects of CSL324 in the Lung After Segmental Challenge

CSL Behring

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: CSL324

Study type: Interventional

Funder types: Industry

Identifiers

NCT05653713

2022-002404-20 (EudraCT Number)

CSL324_1004

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

CSL324

Experimental group

Description:

Intravenous (IV) dose of CSL324

Treatment:

Drug: CSL324

Placebo

Placebo Comparator group

Description:

IV dose of 0.9% saline

Treatment:

Drug: Placebo