Clinical Trial
Study Details
300 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.
1000 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.
2000 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.
4000 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.
Orange juice vehicle, a solution that is highly similar in appearance to the Aes-103 orange juice solution.
The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of Aes-103 (active ingredient 5-hydroxymethyl-2-furfural \[5-HMF\]) compared with placebo in subjects with stable sickle cell disease (SCD). Safety will be measured by monitoring adverse events (AEs), electrocardiograms (ECGs), vital signs, and laboratory values. Pharmacokinetics of Aes-103 will be measured over time in plasma, red blood cell hemolysate and binding of Aes-103 to hemoglobin. Pharmacodynamic effects will be assessed by measuring partial pressure of oxygen at which 50% of hemoglobin is saturated with oxygen (p50) while breathing normal air, blood oxygen levels (SpO2), ex-vivo antisickling effects in a hypoxic environment, and by imaging related changes in tissue blood flow and oxygen levels.
Study Overview
Contacts and Locations
US National Institutes of Health - National Heart, Lung, and Blood Institute
Bethesda, Maryland 20892
United States