HealthyPhase 1NCT04570267
Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects
A Phase 1 study testing CSL324 in people with Healthy, run by CSL Behring at 1 site in Australia.
Trial summary
Study CSL324_1003 is a single center, randomized, double-blind, placebo-controlled study designed to characterize and compare the PK properties and safety of a single subcutaneous dose of CSL324 in healthy Japanese and White subjects. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Oct 2020to 9 Dec 2021
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female Japanese or White subjects aged 20 and 55 years, inclusive
- Body weight of at least 45 kg to 100 kg, inclusive
- Body mass index of 18.0 to 32.0 kg/m2, inclusive
Who cannot join
- A clinically significant medical condition, disorder, or disease of any organ system.
- Concurrent diagnosis of malignancy or history of malignancy (except for nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for at least 3 months before Screening).
- Immunosuppressive conditions and / or currently taking immunosuppressive or immunomodulative therapy.
- Clinically significant abnormalities on physical examination, vital signs, or laboratory assessments, or neutropenia (defined as absolute neutrophil count < 2.0 × 109/L).
- History of chronic or recurrent infections, clinical signs of active infection and / or fever, current / history of serious infection or hospitalized or received IV antibiotics for an infection in previous 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects
Study CSL324_1003 is a single center, randomized, double-blind, placebo-controlled study designed to characterize and compare the PK properties and safety of a single subcutaneous dose of CSL324 in healthy Japanese and White subjects.
- Conditions
- Healthy
- Being tested
- CSL324, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL324Biological
Also called Recombinant Anti G-CSF Receptor Monoclonal Antibody
Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection
PlaceboDrug
Sterile solution of CSL324 formulation buffer for injection
| Study group | Role | What they receive |
|---|---|---|
| CSL324 (Low dose) | Experimental | One low dose of CSL324 administered subcutaneously on Day 1 Receives: Biological: CSL324 |
| CSL324 (High dose) | Experimental | One high dose of CSL324 administered subcutaneously on Day 1 Receives: Biological: CSL324 |
| Placebo | Placebo comparator | One dose of placebo administered subcutaneously on Day 1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) of CSL324 in serum
Measured: From Day 1 to Day 56
Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL324 in serum
Measured: From Day 1 to Day 56
Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL324 in serum
Measured: From Day 1 to Day 56
Secondary outcomes (10)
Number of subjects with treatment-emergent adverse events (TEAEs) by incidence, by severity, and by causality
Measured: Up to Day 56
Percentage of subjects with TEAEs by incidence, by severity, and by causality
Measured: Up to Day 56
Number of subjects with adverse events localized to the administration site by incidence, by severity, and by causality
Measured: Up to Day 7
Percentage of subjects with adverse events localized to the administration site by incidence, by severity, and by causality
Measured: Up to Day 7
Time to reach Cmax (Tmax) for CSL324 in serum
Measured: From Day 1 to Day 56
Terminal half-life (t1/2) for CSL324 in serum
Measured: From Day 1 to Day 56
Apparent clearance (CL/F) for CSL324 in serum
Measured: From Day 1 to Day 56
Apparent volume of distribution (Vz/F) for CSL324 in serum
Measured: From Day 1 to Day 56
Number of subjects with or without anti-CSL324 antibodies
Measured: Up to Day 56
Percentage of subjects with or without anti-CSL324 antibodies
Measured: Up to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start8 Oct 2020
- Primary completion17 Nov 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT04570267
- Sponsor's protocol ID
- CSL324_1003
- Status last verified
- Oct 2022
- First submitted
- 25 Sep 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects
- ClinicalTrials.gov ID
- NCT04570267
- Acronym / sponsor ID
- CSL324_1003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 30 Sep 2020 (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.
Study CSL324_1003 is a single center, randomized, double-blind, placebo-controlled study designed to characterize and compare the PK properties and safety of a single subcutaneous dose of CSL324 in healthy Japanese and White subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CSL324 (Low dose) | Experimental | Biological: CSL324One low dose of CSL324 administered subcutaneously on Day 1 |
| CSL324 (High dose) | Experimental | Biological: CSL324One high dose of CSL324 administered subcutaneously on Day 1 |
| Placebo | Placebo comparator | Drug: PlaceboOne dose of placebo administered subcutaneously on Day 1 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female Japanese or White subjects aged 20 and 55 years, inclusive
- Body weight of at least 45 kg to 100 kg, inclusive
- Body mass index of 18.0 to 32.0 kg/m2, inclusive
Key exclusion criteria (5 listed)
- A clinically significant medical condition, disorder, or disease of any organ system.
- Concurrent diagnosis of malignancy or history of malignancy (except for nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for at least 3 months before Screening).
- Immunosuppressive conditions and / or currently taking immunosuppressive or immunomodulative therapy.
- Clinically significant abnormalities on physical examination, vital signs, or laboratory assessments, or neutropenia (defined as absolute neutrophil count < 2.0 × 109/L).
- History of chronic or recurrent infections, clinical signs of active infection and / or fever, current / history of serious infection or hospitalized or received IV antibiotics for an infection in previous 2 months.
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 G-CSF Receptor Monoclonal AntibodySterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection | Biological | CSL324 (High dose), CSL324 (Low dose) |
| PlaceboSterile solution of CSL324 formulation buffer for injection | Drug | Placebo |
Primary outcome
Maximum concentration (Cmax) of CSL324 in serum
Time frame: From Day 1 to Day 56
Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL324 in serum
Time frame: From Day 1 to Day 56
Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL324 in serum
Time frame: From Day 1 to Day 56
10 secondary outcomes
Number of subjects with treatment-emergent adverse events (TEAEs) by incidence, by severity, and by causality
Time frame: Up to Day 56
Percentage of subjects with TEAEs by incidence, by severity, and by causality
Time frame: Up to Day 56
Number of subjects with adverse events localized to the administration site by incidence, by severity, and by causality
Time frame: Up to Day 7
Percentage of subjects with adverse events localized to the administration site by incidence, by severity, and by causality
Time frame: Up to Day 7
Time to reach Cmax (Tmax) for CSL324 in serum
Time frame: From Day 1 to Day 56
Terminal half-life (t1/2) for CSL324 in serum
Time frame: From Day 1 to Day 56
Apparent clearance (CL/F) for CSL324 in serum
Time frame: From Day 1 to Day 56
Apparent volume of distribution (Vz/F) for CSL324 in serum
Time frame: From Day 1 to Day 56
Number of subjects with or without anti-CSL324 antibodies
Time frame: Up to Day 56
Percentage of subjects with or without anti-CSL324 antibodies
Time frame: Up to Day 56
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 4 Oct 2022.
- Individual participant dataSharing planned: Yes. CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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, run by CSL Behring at 1 site in Australia.
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 3 inclusion and 5 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 4 Oct 2022. 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 Australia. 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?
Maximum concentration (Cmax) of CSL324 in serum (time frame: From Day 1 to Day 56). The study lists 3 primary outcomes in all. 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 4 Oct 2022.