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

ID: NCT03380780
Status: Recruiting
Phase: Phase 1
Start Date: March 20, 2018
First Submitted: December 13, 2017
Last Updated: February 22, 2018
Results: N/A
Organization: Hoffmann-La Roche
Sponsors & Collaborators: Hoffmann-La Roche
Location: China
Conditions: Healthy Volunteers, Hemophilia A
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Healthy Volunteers

Hemophilia A

Drug: Emicizumab
Other Names
RO5534262
Phase 1

Tracking Information

First Submitted DateDecember 13, 2017
Last Update Posted DateFebruary 22, 2018
Anticipated Start DateMarch 20, 2018
Anticipated Completion DateOctober 30, 2018
Anticipated Primary Completion DateApril 30, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Area Under the Plasma Concentration versus Time Curve (AUC) Between Time Zero Extrapolated to Infinity (AUC0-inf) of Emicizumab [Time Frame: At predefined intervals from Day 1 to end of study (up to 16 weeks)]

  • Maximum Observed Plasma Concentration (Cmax) of Emicizumab [Time Frame: At predefined intervals from Day 1 to end of study (up to 16 weeks)]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • AUC Between Time Zero and the Time of Last Quantifiable Concentration (AUC0-last) of Emicizumab [Time Frame: At predefined intervals from Day 1 to end of study (up to 16 weeks)]

  • Time to Cmax (tmax) of Emicizumab [Time Frame: At predefined intervals from Day 1 to end of study (up to 16 weeks)]

  • Apparent Terminal Half-Life (t1/2) of Emicizumab [Time Frame: At predefined intervals from Day 1 to end of study (up to 16 weeks)]

  • Apparent Clearance (CL/F) of Emicizumab [Time Frame: At predefined intervals from Day 1 to end of study (up to 16 weeks)]

  • Apparent Volume of Distribution (Vz/F) of Emicizumab [Time Frame: At predefined intervals from Day 1 to end of study (up to 16 weeks)]

  • Mean Residence Time (MRT) of Emicizumab [Time Frame: At predefined intervals from Day 1 to end of study (up to 16 weeks)]

  • Percentage of Participants with Adverse Events [Time Frame: From screening to end of study (up to 20 weeks)]

  • Percentage of Participants with Anti-Emicizumab Antibodies [Time Frame: Days 1, 57, and 113]

Original Secondary Outcome Measures

Not Available

Study Design

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

Detailed Description

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
16
Allocation
Not Available
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Healthy Volunteers
Hemophilia A
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Emicizumab

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

Other Names
RO5534262
Study Groups/Cohorts
Emicizumab

Study Arms
Experimental Emicizumab
Drug : Emicizumab
Participants will receive a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab on Day 1.

Arm Intervention/Treatment
Experimental Emicizumab
Drug : Emicizumab

Recruitment Information

Recruitment Status:Recruiting
Enrollment16
Completion DateOctober 30, 2018
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 positive test result at screening
- Any other reason that, in the judgment of the investigator, would render the subject unsuitable for study participation
GenderMale
Age20 Years to 45 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
China

Administrative Information

NCT Number:NCT03380780
Other Study ID Numbers
YP39308
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Hoffmann-La Roche
Collaborators
Not Available
Investigators
Study Director
Clinical Trials
Hoffmann-La Roche