CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Emicizumabdrug
Likely dose
Emicizumab 1 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03380780
NCT03380780Phase 1Completed

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

Hoffmann-La Roche·interventional·Posted Dec 21, 2017·Updated Sep 30, 2019

In Brief

A Phase 1 clinical trial evaluating Emicizumab for Healthy Volunteers and Hemophilia A. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedDec 21, 2017
Enrollment StartMar 12, 2018
Primary CompletionSep 18, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.5 years ago

Interventions

Emicizumabdrug

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