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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 from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Country
- China
Trial Identifier:
NCT03380780 YP39308
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
For the latest version of this information please go to www.forpatients.roche.com