A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers
Condition: Healthy Volunteers; Hemophilia A
MeSH terms: Hemophilia A
Intervention: Emicizumab
Intervention description: Participants will receive a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab on Day 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This single-center, open-label study will evaluate the pharmacokinetics, safety, and
      tolerability of emicizumab following a single subcutaneous (SC) administration to healthy
      Chinese subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Chinese male subjects, aged 20-45 years inclusive at the time of screening

          -  Chinese subjects must have Chinese parents and grandparents, all of whom were born in
             China

          -  A body mass index (BMI) between 19 and 24 kilograms per height in meters squared
             (kg/m^2), inclusive

          -  Able to participate and willing to give written informed consent and to comply with
             the study requirements

        Exclusion Criteria:

          -  Any history or presence of a clinically significant disorder, or any other condition
             or disease which in the judgement of the investigator would place the subject at undue
             risk; interfere with absorption, distribution, metabolism, and excretion of
             emicizumab; or interfere with the ability of the subject to complete the study

          -  Major illness within 1 month prior to dosing, and/or any condition which could relapse
             during or immediately after the study

          -  Use of any prescribed or over-the-counter (OTC) medication or herbal medicine taken
             within 14 days prior to dosing or within 5 times the elimination half-life of the
             medication prior to dosing (whichever is longer), with some exceptions

          -  Any significant donation/loss of blood or plasma (greater than 450 milliliters) within
             the 3 months prior to dosing

          -  Regular smoker with consumption of more than 10 cigarettes per day or the equivalent
             amount of tobacco

          -  Participation within a clinical study with an investigational drug or device within
             the last 3 months prior to dosing

          -  Any clinically relevant history of hypersensitivity or allergic reactions, either
             spontaneous or following drug administration or exposure to foods or environmental
             agents

          -  Previous or concomitant thromboembolic disease such as deep vein thrombosis (DVT) or
             signs of thromboembolic disease, or family history of thromboembolic disorder such as
             serious DVT

          -  At high risk for thrombotic microangiopathy (e.g., have a previous medical or family
             history of thrombotic microangiopathy), in the investigator's judgment

          -  Previous or concomitant autoimmune or connective tissue disease

          -  History of tuberculosis or active tuberculosis with positive test result at screening

          -  Any other reason that, in the judgment of the investigator, would render the subject
             unsuitable for study participation