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

NCT ID: NCT03380780

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2018-09-18

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.

Conditions

Healthy Volunteers; Hemophilia A

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Emicizumab

Group Type: EXPERIMENTAL

Emicizumab

Intervention Type: DRUG

Participants will receive a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab on Day 1.

Interventions

Emicizumab

Participants will receive a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab on Day 1.

Intervention Type: DRUG

Other Intervention Names

RO5534262

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Peking University Third Hospital

Beijing, , China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

YP39308

Identifier Type: -

Identifier Source: org_study_id