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Effects of CSL324 in the Lung After Segmental Challenge

NCT ID: NCT05653713

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2023-07-21

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CSL324

Intravenous (IV) dose of CSL324

Group Type EXPERIMENTAL

CSL324

Intervention Type DRUG

Single intravenous (IV) dose of CSL324

Placebo

IV dose of 0.9% saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV dose of 0.9% saline

Interventions

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CSL324

Single intravenous (IV) dose of CSL324

Intervention Type DRUG

Placebo

IV dose of 0.9% saline

Intervention Type DRUG

Other Intervention Names

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Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody (mAb)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

CSL Behring

Locations

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Fraunhofer Institute for Toxicology and Experimental Medicine

Hanover, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2022-002404-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSL324_1004

Identifier Type: -

Identifier Source: org_study_id