Haemoglobin vesicles as artificial red blood cells developed for use as a transfusion alternative: an open-label, single-centre phase Ib study protocol in Japan.

ABSTRACT:

Introduction

Haemoglobin vesicles (HbVs) (product name, NMU-HbVs [Nara Medical University-Haemoglobin Vesicles]), which contain purified human haemoglobin encapsulated within liposomes, have been developed as a potential alternative to blood transfusions in emergency situations. A previous phase I study examined doses up to 100 mL in 11 healthy volunteers. Here, we describe the protocol for a phase Ib study, wherein we will evaluate the safety and pharmacokinetics of NMU-HbV in healthy Japanese adults.

Methods and analysis

This single-centre, open-label, dose-escalation study will enrol 16 healthy volunteers divided into four cohorts. Planned doses are 100 mL for cohorts 1 and 2, 200 mL for cohort 3 and 400 mL for cohort 4, with infusion rates gradually increasing to a maxim

SUBMITTER: Sakai K 

PROVIDER: S-EPMC12829376 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature