None listed
Conditions
Brief summary
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of single doses of CSL112 after intravenous administration in healthy Japanese and Caucasian subjects. Japanese subjects enrolled in the study will be assigned to Cohorts 1, 2, or 3 in a sequential manner. Caucasian subjects will be enrolled in the study and assigned to Cohort 3 only after subject matching by weight within 15% of the median weight of Japanese subjects in Cohort 3. All subjects will be randomized to treatment (CSL112 or placebo) within their cohort and within their race (Cohort 3 only).
Interventions
CSL112 / placebo will be administered to 3 dose cohorts (each cohort receiving a different dose from the other cohorts) of subjects as a single intravenous infusion into a peripheral or central vein over 2 hours by the Investigator (or delegate). Subjects are dosed on Day 1 and are on site for observation until Day 7. Subjects are brought back to the site between day 30 and 37 for a follow-up observation.
Sponsors
CSL Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 54 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
1. Evidence of a clinically significant medical condition, disorder or disease. 2. Evidence of hepatobiliary disease. 3. 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. 4. Sustained and / or symptomatic hypotension (systolic blood pressure < 90 mmHg). 5. Any major illness requiring hospitalization within the 30 days before the Screening Visit or planned hospitalization at any time during the study. 6. 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. 7. A positive result for HAV antibody, HBV surface antigen, HCV antibody, or HIV -1 and / or 2 antibodies at Screening. 8. Evidence or history of substance or alcohol abuse or a positive drug test or alcohol breath test at Screening or Day -1. 9. Smokers, those who have smoked or used tobacco products within 6 months before Screening 10. 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. 11. Clinically significant abnormalities in vital signs or physical examination at Screening or Day -1 as judged by Investigator and / or Sponsor. 12. A mean QTcF > 450 ms for male subjects or > 470 ms for female subjects at Screening. 13. Subjects who have been a recipient of an organ transplant.
Outcome results
None listed