Healthy Volunteers

A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults

NCT04580654 | PHASE 1 | INTERVENTIONAL

This will be a 2- part, phase 1, open-label, single center, single ascending dose study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of subcutaneous (SC) and intravenous (IV) administration of CSL312 in healthy adult Japanese and Caucasian subjects.

1 Sites

38 Participants

Recruiting

18 Years to 55 Years

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SUBMIT

Anaheim Clinical Trials, LLC

Anaheim,California,United States,92801

Study Eligibility Criteria

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Additional Studies

Additional studies can be found at ClinicalTrials.gov