This is a single-site, single-blind, placebo-controlled, randomized cohort study assessing the safety, tolerability and pharmacokinetics of a blood transfusion drug.
Although a life-saving measure for patients suffering from massive hemorrhage and severe anemia, blood transfusion may result in some serious complications and blood-borne infections, such as hepatitis viruses B and C, human immunodeficiency viruses (HIV), and syphilis. Another challenge posed by hematological drugs is significant changes in blood components and properties during their storage. All this and many other related problems have been stimulating the development of alternatives to donated blood (artificial blood substitutes, including polymerized hemoglobin-based blood substitutes) over the past several decades.
The development of a novel polymerized hemoglobin-based blood substitute may provide additional flexibility in choosing blood replacement methods for patients with severe hemorrhage. This is of particular relevance for the military field where the transportation and storage of blood products are limited and blood transfusion is not always possible.
This is the first clinical trial to evaluate the safety and efficacy of the investigational new drug. In this study, healthy volunteers will be consecutively enrolled and randomly assigned to cohorts of 8 subjects each. The trial is expected to be carried out in several cohorts of healthy individuals allocated to take either the investigational drug or equal volume of placebo in a single dose regimen using various dosages. The total duration of the study for each healthy volunteer will be up to 1 month.
In this project, OCT’s scope of services will cover project management, clinical monitoring, data management, statistical analysis and final report preparation. OCT conducts phase I clinical trials in a variety of therapeutic areas. Our highly professional team of medical writers will guarantee the highest quality of the resulting report and other medical documentation.