A Phase 1, Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CSL346 in Healthy Caucasian and Japanese Adult Subjects

CSL Limited0 个研究点目标入组 82 人开始时间: 2017年11月15日最近更新: 2019年9月30日

适应症

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•1. Healthy caucasian male or female subject aged 20 to 55 years.
•2. Male subjects and their female partners who are of childbearing potential must be using 2 highly effective forms of birth control (1 of which must be a barrier method) starting at Screening and through 90 days after the IV infusion of IP unless (a)-The male subject has undergone effective surgical sterilization prior to entering the clinical study, and/or (b)-The female sexual partner(s) of male subject has undergone effective surgical sterilization prior to the subject entering the clinical study or is (are) post-menopausal.
•3. Healthy, as judged by the investigator, with a clinical assessment to include medical history, physical examination, vital signs, ECG, and clinical laboratory tests with no clinically important findings.
•4. Have a body mass index (BMI) of 18 to 30 kg/m2 and weight > 50 kg.
•PART B: (In addition to inclusion criteria for PART A).1. Must be first generation Japanese, born in Japan and has not lived outside of Japan for greater than 10 years.
•PART C: (In addition to inclusion criteria items 2-4 for PART A). 1. Must be Caucasian or first generation Japanese.

•1. History of any clinically significant disease or disorder
•2. Any positive result on screening for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (anti-HAV; IgM), hepatitis C virus antibodies (anti-HCV) or human immunodeficiency virus (HIV)-1 and/or -2 antibodies
•3. Medical history of heart disease or any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG
•4. History of alcohol, drug, or medication abuse within 1 year of providing informed consent
•5. Smokers, those who have smoked or used tobacco products within 6 months prior to providing informed consent
•6. Known or suspected hypersensitivity to CSL346, or to any excipients of CSL346
•7. Women of childbearing potential
•8. The subject has participated in any other investigational study drug trial within 30 days (or 5 half-lives, whichever is longer) or, has participated in more than 3 clinical studies involving the administration of an investigational agent within the last 12 months prior to the 1st dose of investigational product (IP)
•9. The subject has a history of significant blood loss or has donated more than 500 mL within 90 days prior to the 1st dose of IP
•10. Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results as judged by the investigator and/or sponsor.

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