Effect of Food and Formulation on the Pharmacokinetics, Safety, and Tolerability of GNS561 After One Single Dose (50 and 200mg) in Healthy Volunteers

Inclusion Criteria

• •BMI will be between 18 (inclusive) and 26 kg/m² (inclusive).
• •Participants must be in good general health, with no significant medical history, have no clinically significant (CS) abnormalities on physical examination, vital signs, and 12-lead ECG at Screening and/or before administration of the first dose of study drug
• •Have a Fridericia's correction factor for QT (QTcF) ≤ 450 ms for male participants and ≤ 470 ms for female participants on 12-lead ECG
• •Women subjects of childbearing potential must have a negative serum/urine pregnancy test at screening and baseline
• •Women subjects of childbearing potential and male subjects must agree to use adequate highly effective contraception for the duration of study participation and up to 6 months following completion of therapy
• •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• •Able to understand and provide written informed consent.