Assessment of the Safety, Tolerability and Pharmacokinetics of AV078 in Healthy Volunteers

Key Inclusion Criteria:

1. Healthy male or female as determined by medical evaluation including medicalhistory, psychiatric history, and no clinically significant findings on physicalexamination, laboratory tests, and cardiac monitoring. Slight excursions outside ofnormal limits may be allowed provided they are considered not clinically significantby the investigator.

2. Ages 18-65 years (inclusive), at the time of consent.

3. At least 45 kg with a body mass index (BMI; Quetelet index) in the range 18.0-32.0,at screening.

4. Sufficient intelligence to understand the nature of the trial and any hazards ofparticipating in it. Ability to communicate satisfactorily with the investigator andto participate in, and comply with the requirements of, the entire trial.

5. Willingness to give written consent to participate after reading the information andconsent form, and after having the opportunity to discuss the trial with theinvestigator or their delegate.

6. Agree not to donate blood or blood products during the study and for up to 3 monthsafter the last administration of the trial medication.

7. Have received at least 2 doses of the COVID vaccine (1 dose of the Janssen-Cilagvaccine is acceptable).

Key Exclusion Criteria:

1. Current, or past history of any clinically significant mental or physical illness orcondition that the Investigator concludes would create significant concern forparticipation in the study.

2. Surgery (eg stomach bypass) or medical condition that might affect absorption ofmedicines (cholecystectomy is allowed).

3. Presence or history of severe adverse reaction to any drug or a history ofsensitivity to midazolam (Part E only), fexofenadine (Part E only) and itraconazole (Part D only), or any excipients in the tablets/solutions.

4. History of relevant atopy including any confirmed significant allergic reactionsagainst any drug, or multiple drug allergies (non-active hay fever is acceptable)

5. History of suicidal behaviour or express or have any suicidal ideation on the C-SSRSat screening or admission.

6. Employee of the Sponsor, the CRO and/or study site or their relatives.

7. Unable or unwilling to eat a high-fat breakfast per study requirements (Part Conly).