A phase 1, randomized, double-blind, placebo-controlled study to evaluate the pharmacokinetics, safety, and tolerability of CSL112 in healthy Japanese and Caucasian subjects

Healthy (determined by a comprehensive clinical assessment) male or female adult Japanese or Caucasian subjects with a body weight of >= 45 kg to <= 95 kg and a body mass index of >= 18.0 to <= 29.9 kg/m2. Japanese subjects must be of Japanese descent (ie, born in Japan with 2 Japanese biologic parents and 4 Japanese biologic grandparents) and have not lived outside of Japan for >= 10 successive years. Caucasian subjects must have origins in any of the original peoples of Europe, the Middle East, or North Africa.

Evidence of a clinically significant medical condition, disorder or disease.

Evidence of hepatobiliary disease.

Any clinically significant abnormalities in hematology, biochemistry, or urinalysis as judged by the Investigator and / or study Medical Monitor at Screening and / or Day -1.

Sustained and / or symptomatic hypotension (systolic blood pressure < 90 mmHg).

Any major illness requiring hospitalization within the 30 days before the Screening Visit or planned hospitalization at any time during the study.

Known history of soy bean or peanut allergies, hypersensitivity to the investigational product, or to any excipients of the investigational product or placebo (albumin), or IgA deficiency or antibodies to IgA.

A positive result for HAV antibody, HBV surface antigen, HCV antibody, or HIV -1 and / or 2 antibodies at Screening.

Evidence or history of substance or alcohol abuse or a positive drug test or alcohol breath test at Screening or Day -1.

Smokers, those who have smoked or used tobacco products within 6 months before Screening

Plans to participate in another investigational drug study while enrolled in this study or has participated in any investigational drug study within 30 days (or 5 half-lives, whichever is longer) or more than 3 investigational drug studies within the 12 months before Day 1.

Clinically significant abnormalities in vital signs or physical examination at Screening or Day -1 as judged by Investigator and / or Sponsor.

A mean QTcF > 450 ms for male subjects or > 470 ms for female subjects at Screening.

Subjects who have been a recipient of an organ transplant.