Status:
COMPLETED
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteers
Hemophilia A
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief 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
- 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
- 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
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03380780
Start Date
March 12 2018
End Date
September 18 2018
Last Update
September 30 2019
Active Locations (1)
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1
Peking University Third Hospital
Beijing, China, 100083