Participants will receive, in a random order, a placebo prior to exercise in normoxia, a placebo prior to exercise in hypoxia, 1000 mg of Aes-103 prior to exercise in hypoxia, and 3000 mg of Aes-103 prior to exercise in hypoxia. Each intervention is separated by a 7 day washout period.

Entire Study Population

Sex: Female, Male

Region of Enrollment

Height

Body Mass (kg)

Body Mass Index (BMI)

Fat Mass (kg)

Lean Mass (kg)

Percent Body Fat

Waist Circumference (cm)

Waist-to-Hip Ratio

Maximal oxygen uptake (VO2max (L/min))

VO2max (ml/kg/min)

Maximal heart rate (HRmax (beats/min))

Maximal respiratory exchange ratio (RERmax)

To quantify endurance exercise performance (time trial performance during stationary cycle ergometer exercise) in healthy adult men in four conditions: normoxia (normal oxygen; fraction of inspired oxygen = 0.21) following oral placebo consumption, hypoxia (low oxygen; fraction of inspired oxygen = 0.15) following oral placebo consumption, hypoxia following oral consumption Aes-103 (1000 mg) and hypoxia following oral consumption Aes-103 (3000 mg).

Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Normoxia (21% oxygen)

Palcebo + Normoxia

Randomized crossover assignment for each participant.
Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% Oxygen)

Placebo + Hypoxia

Randomized crossover assignment for each participant.
Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)

1000mg Aes-103 + Hypoxia

Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)

3000mg Aes-103 + Hypoxia

Primary Objective Endurance Exercise Performance

To assess the safety and tolerability of single, escalating oral doses of Aes-103 compared with placebo in healthy adult men at rest and during stationary cycle ergometer exercise in normoxia and hypoxia by monitoring adverse events (AEs), electrocardiograms (ECGs), blood pressure, blood oxygen saturation.

Number of participants receiving placebo in normoxic conditions. Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Normoxia (21% oxygen)

Placebo + Normoxia

Number of participants receiving placebo in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Normoxia (21% oxygen)

Number of participants receiving 1000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)

Number of participants receiving 3000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)

Secondary Objective Safety and Tolerability

Randomized Crossover Assignment

Overall Study

Christopher Bell, Ph.D.

Participants receiving placebo in normoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Normoxia (21% oxygen)

Participants receiving placebo in Hypoxic conditions Randomized crossover assignment for each participant Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% Oxygen)

Participants receiving 1000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen)

1000 mg Aes-103 + Hypoxia

Participants receiving 3000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.
Note: Hypoxia (15% oxygen

Hypoxia 3000 mg Aes-103 + Hypoxia

Hypoxia

Placebo

Single dose of 1000mg Aes-103 dissolved in 100 mL of Tropicana Pure Premium Orange Juice

Aes-103

Single dose of 3000mg Aes-103 dissolved in 100 mL of Tropicana Pure Premium Orange Juice

Department of Health and Exercise Science, Colorado State University

Initial Safety Trial For Treatments Under Investigation In Current Study

Colorado State University, Dept. of Health and Exercise Science

Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance

Double-Blind, Placebo Controlled Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance in Healthy Adult Humans

furfural/hypoxia

Evaluation of the Attenuation by Aes-103 of Hypoxia Mediated Decrements in Endurance Exercise Performance

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