A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults
NCT ID: NCT04580654
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2020-10-29
2021-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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CSL312 (Cohort 1a, low dose)
Factor XIIa antagonist monoclonal antibody administered subcutaneously
CSL312
Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
CSL312 (Cohort 1b, low dose)
Factor XIIa antagonist monoclonal antibody administered subcutaneously
CSL312
Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
CSL312 (Cohort 2, high dose)
Factor XIIa antagonist monoclonal antibody administered subcutaneously
CSL312
Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
CSL312 (Cohort 3, low dose)
Factor XIIa antagonist monoclonal antibody administered intravenously
CSL312
Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
CSL312 (Cohort 4, high dose)
Factor XIIa antagonist monoclonal antibody administered intravenously
CSL312
Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
Interventions
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CSL312
Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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Anaheim Clinical Trials, LLC
Anaheim, California, United States
Countries
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Other Identifiers
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CSL312_1003
Identifier Type: -
Identifier Source: org_study_id
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