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

October 3, 2022 updated by: CSL Behring

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CSL312 (Cohort 1a, low dose)
Factor XIIa antagonist monoclonal antibody administered subcutaneously
Biological: CSL312
Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
Other Names:
  • Factor XIIa antagonist monoclonal antibody
  • garadacimab
Experimental: CSL312 (Cohort 1b, low dose)
Factor XIIa antagonist monoclonal antibody administered subcutaneously
Biological: CSL312
Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
Other Names:
  • Factor XIIa antagonist monoclonal antibody
  • garadacimab
Experimental: CSL312 (Cohort 2, high dose)
Factor XIIa antagonist monoclonal antibody administered subcutaneously
Biological: CSL312
Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
Other Names:
  • Factor XIIa antagonist monoclonal antibody
  • garadacimab
Experimental: CSL312 (Cohort 3, low dose)
Factor XIIa antagonist monoclonal antibody administered intravenously
Biological: CSL312
Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
Other Names:
  • Factor XIIa antagonist monoclonal antibody
  • garadacimab
Experimental: CSL312 (Cohort 4, high dose)
Factor XIIa antagonist monoclonal antibody administered intravenously
Biological: CSL312
Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
Other Names:
  • Factor XIIa antagonist monoclonal antibody
  • garadacimab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum plasma concentration (Cmax) of CSL312 after subcutaneous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-inf) of CSL312 after subcutaneous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to maximum concentration (Tmax) of CSL312 after subcutaneous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL312 after subcutaneous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Half-life (t1/2) of CSL312 after subcutaneous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Apparent clearance (CL/F) of CSL312 after subcutaneous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Apparent volume of distribution (Vz/F) of CSL312 after subcutaneous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Cmax of CSL312 after intravenous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Tmax of CSL312 after intravenous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose
AUC0-last of CSL312 after intravenous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose
AUC0-inf of CSL312 after intravenous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose
t1/2 of CSL312 after intravenous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Clearance (CL) of CSL312 after intravenous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Volume of distribution (Vd) of CSL312 after intravenous dosing
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Mean FXIIa-mediated kallikrein activity
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Number of subjects experiencing adverse events (AEs)
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Percentage of subjects experiencing AEs
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Number of subjects experiencing serious adverse events (SAEs)
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Percentage of subjects experiencing SAEs
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Number of subjects experiencing adverse events of special interest (AESIs)
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Percentage of subjects experiencing AESIs
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Number of subjects experiencing Anti-CSL312 antibodies
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Percentage of subjects experiencing Anti-CSL312 antibodies
Time Frame: Up to 85 days postdose
Up to 85 days postdose
Number of subjects with injection / infusion site reaction by severity
Time Frame: Up to 48 hours after start of infusion or injection
Up to 48 hours after start of infusion or injection
Percentage of subjects with injection / infusion site reaction by severity
Time Frame: Up to 48 hours after start of infusion or injection
Up to 48 hours after start of infusion or injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSL Behring

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 7, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSL312_1003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.

IPD Sharing Access Criteria

Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.

An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.

The requesting party must execute an appropriate data sharing agreement before IPD will be made available.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on CSL312

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings