Healthy VolunteersPhase 1NCT05653713
Effects of CSL324 in the Lung After Segmental Challenge
A Phase 1 study testing CSL324 in people with Healthy Volunteers, run by CSL Behring at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CSL324
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 20 Dec 2022to 21 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer Institute for Toxicology and Experimental Medicine
Hanover, 30625
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- CSL324, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL324Drug
Also called Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody (mAb)
Single intravenous (IV) dose of CSL324
PlaceboDrug
IV dose of 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| CSL324 | Experimental | Intravenous (IV) dose of CSL324 Receives: Drug: CSL324 |
| Placebo | Placebo comparator | IV dose of 0.9% saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in mean absolute neutrophil cell counts in bronchoalveolar lavage fluid (BALF) between CSL324 and placebo
Measured: Obtained at 24 hours after the segmental lipopolysaccharide (LPS) challenge with endotoxin in the lung
Secondary outcomes (14)
Percent reduction in the mean change in biomarkers of neutrophil activation in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Biomarkers are (neutrophil elastase [NE], alpha [α] 1 antitrypsin [AAT) complex, and myeloperoxidase [MPO]) in BALF
Measured: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Percent reduction in the mean change in total protein in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Measured: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Percent reduction in the mean change in concentrations of von Willebrand factor (vWF) in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Measured: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Percent reduction in the mean change in concentrations of surfactant protein D (SP D) in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Measured: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Percent reduction in the mean change in concentrations of sRAGE in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Measured: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Percent reduction in the mean change in concentrations of G CSF in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Measured: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Percent reduction in the mean change in concentrations of VEGF A in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Measured: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Serum concentration of CSL324
Measured: Up to 6 days after CSL324 administration
Number of subjects with antidrug antibodies (ADAs) to CSL324 in serum
Measured: Prior to and up to 6 days after CSL324 and placebo administration
Number and percentage of subjects with treatment-emergent adverse events (TEAEs) by treatment group
Measured: Up to 32 days after CSL324 and placebo administration
Maximum plasma concentration (Cmax)
Measured: Prior to and up to 6 days after CSL324 administration
Time to reach Cmax (Tmax)
Measured: Prior to and up to 6 days after CSL324 administration
Area under the plasma concentration-time curve from time 0 to 120 hours (AUC0-120h)
Measured: Time 0 to 120 hours after CSL324 administration
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-last)
Measured: Time 0 and up to 6 days after CSL324 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start20 Dec 2022
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653713
- Sponsor's protocol ID
- CSL324_1004
- Other IDs
- 2022-002404-20
- Status last verified
- Nov 2023
- First submitted
- 8 Dec 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05653713
- Acronym / sponsor ID
- CSL324_1004
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSL324 | Experimental | Drug: CSL324Intravenous (IV) dose of CSL324 |
| Placebo | Placebo comparator | Drug: PlaceboIV dose of 0.9% saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSL324Also: Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody (mAb)Single intravenous (IV) dose of CSL324 | Drug | CSL324 |
| PlaceboIV dose of 0.9% saline | Drug | Placebo |
Primary outcome
Percent reduction in mean absolute neutrophil cell counts in bronchoalveolar lavage fluid (BALF) between CSL324 and placebo
Time frame: Obtained at 24 hours after the segmental lipopolysaccharide (LPS) challenge with endotoxin in the lung
14 secondary outcomes
Percent reduction in the mean change in biomarkers of neutrophil activation in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Percent reduction in the mean change in total protein in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Percent reduction in the mean change in concentrations of von Willebrand factor (vWF) in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Percent reduction in the mean change in concentrations of surfactant protein D (SP D) in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Percent reduction in the mean change in concentrations of sRAGE in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Percent reduction in the mean change in concentrations of G CSF in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Percent reduction in the mean change in concentrations of VEGF A in BALF from Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung between CSL324 and placebo
Time frame: Baseline to 24 hours after segmental LPS challenge with endotoxin in the lung
Serum concentration of CSL324
Time frame: Up to 6 days after CSL324 administration
Number of subjects with antidrug antibodies (ADAs) to CSL324 in serum
Time frame: Prior to and up to 6 days after CSL324 and placebo administration
Number and percentage of subjects with treatment-emergent adverse events (TEAEs) by treatment group
Time frame: Up to 32 days after CSL324 and placebo administration
Maximum plasma concentration (Cmax)
Time frame: Prior to and up to 6 days after CSL324 administration
Time to reach Cmax (Tmax)
Time frame: Prior to and up to 6 days after CSL324 administration
Area under the plasma concentration-time curve from time 0 to 120 hours (AUC0-120h)
Time frame: Time 0 to 120 hours after CSL324 administration
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-last)
Time frame: Time 0 and up to 6 days after CSL324 administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: Yes. CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
CSL Behring
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CSL324 in people with Healthy Volunteers, run by CSL Behring at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction in mean absolute neutrophil cell counts in bronchoalveolar lavage fluid (BALF) between CSL324 and placebo (time frame: Obtained at 24 hours after the segmental lipopolysaccharide (LPS) challenge with endotoxin in the lung). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.