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

Inclusion criteria

• Healthy male and female subjects;
• Between 18 and 55 years of age;
• Provide a signed EC-approved consent form;
• Generally healthy, in the opinion of the Investigator;
• Body Mass Index (BMI) 18 to 30 kg/m^2;
• Creatinine clearance with in specific parameter;
• Using method of contraception;
• Willing and able to comply with protocol requirements for the duration of the study.

Exclusion criteria

• Subjects taking prohibited medication;
• Subjects with a history or presence of clinically significant medical or psychiatric disease;
• Subjects who have regularly used nicotine-containing products ;
• Subjects who have used caffeine-containing products;
• Subjects who are unable to comply with eating a standardized meal during the study;
• Subjects with a hospital admission or major surgery within 30 days prior to Screening;
• Subjects with a plasma donation within 7 days prior to Screening;
• 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;
• Subjects who cannot refrain from strenuous exercise from 72 hours prior to dose administration through completion of the Follow-up Visit;
• Subjects who are pregnant or breastfeeding
• Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 90 days prior to Screening;
• 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.