Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CSL Behring
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults