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

• Status: Completed
• Trial end date: 2018-09-18
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche

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