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

CSL Behring

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: CSL312

Study type: Interventional

Funder types: Industry

Identifiers

NCT04580654

CSL312_1003

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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38 participants in 5 patient groups

CSL312 (Cohort 1a, low dose)

Experimental group

Description:

Factor XIIa antagonist monoclonal antibody administered subcutaneously

Treatment:

Biological: CSL312

CSL312 (Cohort 1b, low dose)

Experimental group

Description:

Factor XIIa antagonist monoclonal antibody administered subcutaneously

Treatment:

Biological: CSL312

CSL312 (Cohort 2, high dose)

Experimental group

Description:

Factor XIIa antagonist monoclonal antibody administered subcutaneously

Treatment:

Biological: CSL312

CSL312 (Cohort 3, low dose)

Experimental group

Description:

Factor XIIa antagonist monoclonal antibody administered intravenously

Treatment:

Biological: CSL312

CSL312 (Cohort 4, high dose)

Experimental group

Description:

Factor XIIa antagonist monoclonal antibody administered intravenously

Treatment:

Biological: CSL312