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Healthy VolunteersPhase 1NCT04580654

A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults

A Phase 1 study testing CSL312 in people with Healthy Volunteers, run by CSL Behring at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be a 2- part, phase 1, open-label, single center, single ascending dose study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of subcutaneous (SC) and intravenous (IV) administration of CSL312 in healthy adult Japanese and Caucasian 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 Volunteers
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
38 participants
Where
1 siteUnited States
Study dates
29 Oct 2020to 7 May 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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy Caucasian and Japanese male or female subjects 18 to 55 years old (inclusive) that meet the following criteria at Screening:
  • Japanese subjects defined as being born in Japan, having not lived outside of Japan for more than 10 years, and having both parents and four grandparents who are of Japanese ancestry.
  • Caucasian subjects, defined as having both parents and four grandparents descended from and of the peoples of Europe, the Middle East, or North Africa, who are body weight-matched (± 15%) 1:1 with Japanese subjects.
  • Body weight in the range of ≥ 50 kg and ≤ 100 kg
  • Body mass index of ≥ 18 kg/m2 and ≤ 30 kg/m2

Who cannot join

  • Positive serology test for human immunodeficiency virus (HIV)-1 / 2 antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis C virus (HCV) antibody.
  • 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.
  • Evidence of current active infection.
  • Known malignancy or a history of malignancy in the past 5 years .
  • Blood pressure or pulse rate measurements outside the normal range for the subject's age.
  • Female subject of childbearing potential or fertile male subject either not using or not willing to use an acceptable method of contraception
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  • Pregnant, breastfeeding, or not willing to cease breastfeeding.
  • Donation or loss of more than 500 mL of blood within 3 months, or donated plasma within 7 days
  • History of clinically significant arterial or venous thrombosis, bleeding disorder, or any abnormal coagulation test result

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

Other trials in United States

About this study

Official title: A 2-Part, Phase 1, Single Center, Open-label, Single Ascending Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Subcutaneous and Intravenous CSL312 in Healthy Adult Japanese and Caucasian Subjects

This will be a 2- part, phase 1, open-label, single center, single ascending dose study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of subcutaneous (SC) and intravenous (IV) administration of CSL312 in healthy adult Japanese and Caucasian subjects.

Being tested
CSL312

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CSL312Biological

    Also called Factor XIIa antagonist monoclonal antibody, garadacimab

    Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa

Study groups in NCT04580654
Study groupRoleWhat they receive
CSL312 (Cohort 1a, low dose)ExperimentalFactor XIIa antagonist monoclonal antibody administered subcutaneously
Receives: Biological: CSL312
CSL312 (Cohort 1b, low dose)ExperimentalFactor XIIa antagonist monoclonal antibody administered subcutaneously
Receives: Biological: CSL312
CSL312 (Cohort 2, high dose)ExperimentalFactor XIIa antagonist monoclonal antibody administered subcutaneously
Receives: Biological: CSL312
CSL312 (Cohort 3, low dose)ExperimentalFactor XIIa antagonist monoclonal antibody administered intravenously
Receives: Biological: CSL312
CSL312 (Cohort 4, high dose)ExperimentalFactor XIIa antagonist monoclonal antibody administered intravenously
Receives: Biological: CSL312

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum plasma concentration (Cmax) of CSL312 after subcutaneous dosing

    Measured: Up to 85 days postdose

  2. Area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-inf) of CSL312 after subcutaneous dosing

    Measured: Up to 85 days postdose

Secondary outcomes (23)

  1. Time to maximum concentration (Tmax) of CSL312 after subcutaneous dosing

    Measured: Up to 85 days postdose

  2. Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL312 after subcutaneous dosing

    Measured: Up to 85 days postdose

  3. Half-life (t1/2) of CSL312 after subcutaneous dosing

    Measured: Up to 85 days postdose

  4. Apparent clearance (CL/F) of CSL312 after subcutaneous dosing

    Measured: Up to 85 days postdose

  5. Apparent volume of distribution (Vz/F) of CSL312 after subcutaneous dosing

    Measured: Up to 85 days postdose

  6. Cmax of CSL312 after intravenous dosing

    Measured: Up to 85 days postdose

  7. Tmax of CSL312 after intravenous dosing

    Measured: Up to 85 days postdose

  8. AUC0-last of CSL312 after intravenous dosing

    Measured: Up to 85 days postdose

  9. AUC0-inf of CSL312 after intravenous dosing

    Measured: Up to 85 days postdose

  10. t1/2 of CSL312 after intravenous dosing

    Measured: Up to 85 days postdose

  11. Clearance (CL) of CSL312 after intravenous dosing

    Measured: Up to 85 days postdose

  12. Volume of distribution (Vd) of CSL312 after intravenous dosing

    Measured: Up to 85 days postdose

  13. Mean FXIIa-mediated kallikrein activity

    Measured: Up to 85 days postdose

  14. Number of subjects experiencing adverse events (AEs)

    Measured: Up to 85 days postdose

  15. Percentage of subjects experiencing AEs

    Measured: Up to 85 days postdose

  16. Number of subjects experiencing serious adverse events (SAEs)

    Measured: Up to 85 days postdose

  17. Percentage of subjects experiencing SAEs

    Measured: Up to 85 days postdose

  18. Number of subjects experiencing adverse events of special interest (AESIs)

    Measured: Up to 85 days postdose

  19. Percentage of subjects experiencing AESIs

    Measured: Up to 85 days postdose

  20. Number of subjects experiencing Anti-CSL312 antibodies

    Measured: Up to 85 days postdose

  21. Percentage of subjects experiencing Anti-CSL312 antibodies

    Measured: Up to 85 days postdose

  22. Number of subjects with injection / infusion site reaction by severity

    Measured: Up to 48 hours after start of infusion or injection

  23. Percentage of subjects with injection / infusion site reaction by severity

    Measured: Up to 48 hours after start of infusion or injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start29 Oct 2020
  3. Primary completion7 May 2021
  4. Study completion7 May 2021

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04580654
Sponsor's protocol ID
CSL312_1003
Status last verified
Oct 2022
First submitted
2 Oct 2020
Last updated
4 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CSL312 in people with Healthy Volunteers, 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 5 inclusion and 9 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 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 after subcutaneous dosing (time frame: Up to 85 days postdose). 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?

On the ClinicalTrials.gov record for NCT04580654.

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.

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