Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
In low oxygen environments, such as high-altitude, some adults may become ill and suffer from
acute mountain sickness. Further, all adults will find that exercising becomes much more
difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of
this investigation is to study the effects of a new medicine called Aes-103. A company called
AesRx, LLC makes this medicine. The active ingredient in the medicine is
5-Hydroxymethyl-2-Furfural (5HMF), a naturally occurring substance that can be found in
coffee, honey, dried fruits, fruit juices, malt, barley, Balsamic vinegar and caramel.The
investigators believe that Aes-103 may help people adjust to high-altitude quickly and
prevent them from becoming ill. The purpose of the study is to determine if Aes-103 will
promote endurance performance in low oxygen environments in healthy adult humans.
Aes-103 is currently being investigated by AesRx, LLC (Newton, MA) in collaboration with the
National Heart, Lung and Blood Institute of the NIH (Bethesda, MD) as a potential
anti-sickling agent in sickle cell disease. Sickle-cell disease is characterized by problems
in blood that prevent blood cells from carrying oxygen. Aes-103 might be able to help blood
cells carry more oxygen. It is for this reason that the investigators in this study believe
Aes-103 might help people adjust to high-altitude quickly.
There are no known special safety considerations with the active ingredient in Aes-103
(5-HMF). In recent, placebo controlled, clinical safety tests, Aes-103 was given in single
doses of 300 mg, 1000 mg,2000 mg and 4000 mg to healthy normal volunteers. Additionally, the
toxicological effects of Aes-103 have been studied when given acutely, sub-acutely, and
chronically in rodents, and for up to 28 days in dogs. Based on these safety studies, single
doses of Aes-103 are expected to have no significant negative/toxicological effect at the
doses being evaluated in this study.