Healthy ParticipantsPhase 1NCT05306275
A Study to Compare the Pharmacokinetics of CSL312 Administered by Prefilled Syringe Assembled to Autoinjector to the Pharmacokinetics Administered by Prefilled Syringe Assembled to Needle Safety Device in Healthy Subjects
A Phase 1 study testing CSL312 in people with Healthy Participants, run by CSL Behring at 1 site in United States.
Trial summary
This is an open-label, parallel-group, phase 1, single center study to assess the relative bioavailability of CSL312 administered subcutaneously via a prefilled syringe assembled to an autoinjector compared to a prefilled syringe assembled to a needle safety device in healthy, adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- CSL312
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2022to 27 Sep 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Male or female 18 to 55 years of age
- Body weight in the range of ≥ 50 kg and ≤ 100 kg, with a body mass index (BMI) of ≥ 18 kg/m2 and ≤ 30 kg/m2
Who cannot join
- Received any live viral or bacterial vaccinations within 8 weeks of Screening or is expected to receive any live virus or bacterial vaccinations during the study or up to 4 months after last administration of the investigational product.
- Evidence of current active infection, including severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
- Blood pressure or pulse rate measurements outside the normal range for the subject's age
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
About this study
Official title: A Phase 1, Randomized, Open-label, Parallel-group Study to Compare the Pharmacokinetic Properties of CSL312 Administered by Subcutaneous Prefilled Syringe Assembled to Autoinjector to Prefilled Syringe Assembled to Needle Safety Device in Healthy Adult Subjects
This is an open-label, parallel-group, phase 1, single center study to assess the relative bioavailability of CSL312 administered subcutaneously via a prefilled syringe assembled to an autoinjector compared to a prefilled syringe assembled to a needle safety device in healthy, adult subjects.
- Conditions
- Healthy Participants
- Being tested
- CSL312
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL312Drug
Also called Gardacimab
Factor XIIa antagonist monoclonal antibody for subcutaneous use
| Study group | Role | What they receive |
|---|---|---|
| CSL312 AI Abdomen | Experimental | CSL312 administered subcutaneously (SC) in the abdomen via a prefilled syringe assembled to an autoinjector (AI) Receives: Drug: CSL312 |
| CSL312 AI Thigh | Experimental | CSL312 administered SC in the thigh via a prefilled syringe assembled to an AI Receives: Drug: CSL312 |
| CSL312 AI Arm | Experimental | CSL312 administered SC in the upper arm via a prefilled syringe assembled to an AI Receives: Drug: CSL312 |
| CSL312 NSD Abdomen | Experimental | CSL312 administered SC in the abdomen via a prefilled syringe assembled to a needle safety device (NSD) Receives: Drug: CSL312 |
| CSL312 NSD Thigh | Experimental | CSL312 administered SC in the thigh via a prefilled syringe assembled to a NSD Receives: Drug: CSL312 |
| CSL312 NSD Arm | Experimental | CSL312 administered SC in the upper arm via a prefilled syringe assembled to a NSD Receives: Drug: CSL312 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of CSL312
Measured: Up to 85 days post-dose
Area under the concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC0-inf) of CSL312
Measured: Up to 85 days post-dose
Secondary outcomes (11)
Number and percentage of subjects experiencing adverse events (AEs)
Measured: Up to 85 days post-dose
Number and percentage of subjects experiencing serious adverse events (SAEs)
Measured: Up to 85 days post-dose
Number and percentage of subjects experiencing adverse events of special interest (AESIs)
Measured: Up to 85 days post-dose
Number and percentage of subjects developing Anti-CSL312 antibodies
Measured: Up to 85 days post-dose
Number and percentage of subjects with clinically significant laboratory abnormalities that are reported as AEs
Measured: Up to 85 days post-dose
Number and percentage of subjects with injection site reactions by severity
Measured: Up to 48 hours post-injection
Time to maximum plasma concentration (Tmax) of CSL312
Measured: Up to 85 days post-dose
AUC from time 0 to the last measurable concentration (AUC0-last) of CSL312
Measured: Up to 85 days post-dose
Half-life (t1/2) of CSL312
Measured: Up to 85 days post-dose
Apparent clearance (CL/F) of CSL312
Measured: Up to 85 days post-dose
Apparent volume of distribution (Vz/F) of CSL312
Measured: Up to 85 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start4 Apr 2022
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 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
- NCT05306275
- Sponsor's protocol ID
- CSL312_1004
- Status last verified
- Oct 2022
- First submitted
- 23 Mar 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Parallel-group Study to Compare the Pharmacokinetic Properties of CSL312 Administered by Subcutaneous Prefilled Syringe Assembled to Autoinjector to Prefilled Syringe Assembled to Needle Safety Device in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05306275
- Acronym / sponsor ID
- CSL312_1004
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 1 Apr 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 an open-label, parallel-group, phase 1, single center study to assess the relative bioavailability of CSL312 administered subcutaneously via a prefilled syringe assembled to an autoinjector compared to a prefilled syringe assembled to a needle safety device in healthy, adult subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CSL312 AI Abdomen | Experimental | Drug: CSL312CSL312 administered subcutaneously (SC) in the abdomen via a prefilled syringe assembled to an autoinjector (AI) |
| CSL312 AI Thigh | Experimental | Drug: CSL312CSL312 administered SC in the thigh via a prefilled syringe assembled to an AI |
| CSL312 AI Arm | Experimental | Drug: CSL312CSL312 administered SC in the upper arm via a prefilled syringe assembled to an AI |
| CSL312 NSD Abdomen | Experimental | Drug: CSL312CSL312 administered SC in the abdomen via a prefilled syringe assembled to a needle safety device (NSD) |
| CSL312 NSD Thigh | Experimental | Drug: CSL312CSL312 administered SC in the thigh via a prefilled syringe assembled to a NSD |
| CSL312 NSD Arm | Experimental | Drug: CSL312CSL312 administered SC in the upper arm via a prefilled syringe assembled to a NSD |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Male or female 18 to 55 years of age
- Body weight in the range of ≥ 50 kg and ≤ 100 kg, with a body mass index (BMI) of ≥ 18 kg/m2 and ≤ 30 kg/m2
Key exclusion criteria (3 listed)
- Received any live viral or bacterial vaccinations within 8 weeks of Screening or is expected to receive any live virus or bacterial vaccinations during the study or up to 4 months after last administration of the investigational product.
- Evidence of current active infection, including severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
- Blood pressure or pulse rate measurements outside the normal range for the subject's age
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 |
|---|---|---|
| CSL312Also: GardacimabFactor XIIa antagonist monoclonal antibody for subcutaneous use | Drug | CSL312 AI Abdomen, CSL312 AI Arm, CSL312 AI Thigh, CSL312 NSD Abdomen, CSL312 NSD Arm, CSL312 NSD Thigh |
Primary outcome
Maximum plasma concentration (Cmax) of CSL312
Time frame: Up to 85 days post-dose
Area under the concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC0-inf) of CSL312
Time frame: Up to 85 days post-dose
11 secondary outcomes
Number and percentage of subjects experiencing adverse events (AEs)
Time frame: Up to 85 days post-dose
Number and percentage of subjects experiencing serious adverse events (SAEs)
Time frame: Up to 85 days post-dose
Number and percentage of subjects experiencing adverse events of special interest (AESIs)
Time frame: Up to 85 days post-dose
Number and percentage of subjects developing Anti-CSL312 antibodies
Time frame: Up to 85 days post-dose
Number and percentage of subjects with clinically significant laboratory abnormalities that are reported as AEs
Time frame: Up to 85 days post-dose
Number and percentage of subjects with injection site reactions by severity
Time frame: Up to 48 hours post-injection
Time to maximum plasma concentration (Tmax) of CSL312
Time frame: Up to 85 days post-dose
AUC from time 0 to the last measurable concentration (AUC0-last) of CSL312
Time frame: Up to 85 days post-dose
Half-life (t1/2) of CSL312
Time frame: Up to 85 days post-dose
Apparent clearance (CL/F) of CSL312
Time frame: Up to 85 days post-dose
Apparent volume of distribution (Vz/F) of CSL312
Time frame: Up to 85 days post-dose
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 6 Oct 2022.
- 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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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 CSL312 in people with Healthy Participants, run by CSL Behring at 1 site in United States.
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 2 inclusion and 3 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 6 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 United States. 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. 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 plasma concentration (Cmax) of CSL312 (time frame: Up to 85 days post-dose). The study lists 2 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 6 Oct 2022.