CompletedPhase 1ACTRN12618000805279

Assessing the pharmacokinetics, safety, and tolerability of CSL112 in healthy Japanese and Caucasian adults

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

Sponsor

CSL Limited

Enrollment

52 participants

Start Date

May 16, 2018

Study Type

Interventional

Conditions

Acute Coronary Syndrome

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).

Eligibility

Sex: Both males and femalesMin Age: 20 YearssMax Age: 54 Yearss

Inclusion Criteria1

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 Criteria13

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.

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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.