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

NCT03380780 | Completed Phase 1 Results

• 1 other identifier: YP39308
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax) of Emicizumab

  Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.

  Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

• Area Under the Plasma Concentration Versus Time Curve (AUC) Between Time Zero Extrapolated to Infinity (AUC0-inf) of Emicizumab

  Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.

  Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Secondary Outcomes (62)

• AUC Between Time Zero and the Time of Last Quantifiable Concentration (AUC0-last) of Emicizumab

  Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

• Time to Cmax (Tmax) of Emicizumab

  Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

• Apparent Terminal Half-Life (t1/2) of Emicizumab

  Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

• Apparent Clearance (CL/F) of Emicizumab

  Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

• Apparent Volume of Distribution (Vz/F) of Emicizumab

  Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113

Study Arms (1)

Emicizumab

EXPERIMENTAL

Drug: Emicizumab

Interventions

Emicizumab DRUG

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

Also known as: RO5534262

Emicizumab

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100083, China

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

emicizumab

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 21, 2017
• Study Start: March 12, 2018
• Primary Completion: September 18, 2018
• Study Completion: September 18, 2018
• Last Updated: September 30, 2019
• Results First Posted: September 30, 2019

Record last verified: 2019-09

Locations

CN (1)