A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers

  • Hemophilia
  • Hemophilia A
  • Healthy Volunteers
Please note that the recruitment status of the trial at your site may differ.
Trial Status:

Completed

This trial runs in
Countries
  • China
Trial Identifier:

NCT03380780 YP39308

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT03380780,YP39308 Trial Identifier
      Emicizumab Treatments
      Healthy Volunteers, Hemophilia A Condition
      Official Title

      A Single-Center, Open-Label, Single Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers

      Eligibility Criteria

      Male Gender
      ≥ 20 Years & ≤ 45 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      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

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