Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GEn1E-1124

Inclusion Criteria: 1. Healthy male and female subjects; 2. Between 18 and 55 years of age; 3. Provide a signed EC-approved consent form; 4. Generally healthy, in the opinion of the Investigator; 5. Body Mass Index (BMI) 18 to 30 kg/m\^2; 6. Creatinine clearance with in specific parameter; 7. Using method of contraception; 8. Willing and able to comply with protocol requirements for the duration of the study. Exclusion Criteria: 1. Subjects taking prohibited medication; 2. Subjects with a history or presence of clinically significant medical or psychiatric disease; 3. Subjects who have regularly used nicotine-containing products ; 4. Subjects who have used caffeine-containing products; 5. Subjects who are unable to comply with eating a standardized meal during the study; 6. Subjects with a hospital admission or major surgery within 30 days prior to Screening; 7. Subjects with a plasma donation within 7 days prior to Screening; 8. Subjects who have not abstained from alcoholic beverages/alcohol-containing products at least 72 hours prior to first dose, or plan to consume them at any time through completion of the Follow-up Visit; 9. Subjects who cannot refrain from strenuous exercise from 72 hours prior to dose administration through completion of the Follow-up Visit; 10. Subjects who are pregnant or breastfeeding 11. Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 90 days prior to Screening; 12. Subjects who are employees of the study unit or their family members, students who are working in the study unit, or family members of the Investigator or Sponsor.