NCT03380780

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2018-03-12
• Primary completion: 2018-09-18
• Completion: 2018-09-18
• First posted: 2017-12-21
• Last updated: 2019-09-30
• Results posted: 2019-09-30

Locations

1 site across 1 country: China