A healthy volunteer study to asses the safety, tolerability and blood levels of AUT00206 tablets

INTERVENTION: Part A1: Single Ascending Dose, cross‐over design; subjects will be dosed in up to 4 sessions. Group 1 males ‐ 6 subjects AUT00206 active; 2 subjects placebo to match Optional Part A2: Single Ascending Dose. Cross‐over design; subjects will be dosed in up to 2 sessions. Group 1 females ‐ 6 subjects AUT00206 active; 2 subjects placebo to match Optional PART B: Multiple Ascending Dose (7 ‐ 10 days, based on predicted time to steady state) Group 1 ‐ 6 subjects AUT00206 active; 2 placebo Group 2 ‐ 6 subjects AUT00206 active; 2 placebo Group 3 ‐ 6 subjects AUT00206 active; 2 placebo Group 4 ‐ 6 subjects AUT00206 active; 2 placebo All subjects will be dosed orally. Whether subjects receive either a single dose or 2 single doses (one in the morning and one in the evening) of AUT00206 or placebo, and whether the dose is taken fed or fasted, will be determined based on the pharmacokinetic data as it becomes available. CONDITION: Phase 1 study in healthy volunteers of a treatment to improve and/or normalize symptoms and deficits in patients with Fragile X Syndrome (FXS) ; Not Applicable PRIMARY OUTCOME: ; Part A1:; 1.1 Pharmacokinetic (PK) profile of AUT00206 after single oral doses of AUT00206 in healthy men measured from blood samples taken before and frequently after dosing up to 192h; 1.2 Effect of food on the bioavailability of single oral doses of AUT00206 in healthy men measured from blood samples taken before and frequently after dosing; ; Part A2 (optional):; 2. PK profile of AUT00206 after single oral doses of AUT00206 in healthy women measured from blood samples taken before and frequently after dosing up to 192h; ; Part B (optional):; 3. PK profile of AUT00206 after repeated oral doses of AUT00206 in healthy men measured from blood samples taken before and frequently after dosing up to 192h; SECONDARY OUTCOME: ; Part A1:; 1. Safety and tolerability of single oral doses of AUT00206 in healthy men measured by collecting vital signs (blood pressure, heart rate, tympanic temperature, and respiratory rate), 12‐lead electrocardiogram (ECG)s, physical examinations, and laboratory safety tests (haematology, clinical chemistry, thyroid function, and urinalysis), at frequent intervals; the Columbia‐Suicide Severity Rating Scale (C‐SSRS) will be conducted at Screening and follow‐up, and collecting reports of adverse events (AEs) throughout the study; ; Part A2 (optional):; 2. Safety and tolerability of single oral doses of AUT00206 in healthy women measured by collecting vital signs (blood pressure, heart rate, tympanic temperature, and respiratory rate), 12‐lead electrocardiogram (ECG)s, physical examinations, and laboratory safety tests (haematology, clinical chemistry, thyroid function, and urinalysis), at frequent intervals; the Columbia‐Suicide Severity Rating Scale (C‐SSRS) will be conducted at Screening and follow‐up, and collecting reports of adverse events (AEs) throughout the study; ; Part B (optional):; 3. To assess the safety and tolerability of repeated oral doses of AUT00206 in healthy men measured by collecting vital signs (blood pressure, heart rate, tympanic temperature, and respiratory rate), 12‐lead electrocardiogram (ECG)s, physical examinations, and laboratory safety tests (haematology, clinical chemistry, thyroid function, and urinalysis), at frequent intervals; the Columbia‐Suicide Severity Rating Scale (C‐SSRS) will be conducted at Screening and follow‐up, and collecting reports of adverse events (AEs) throughout the study; INCLUSION CRITERIA: 1. Healthy male volunteer (Parts A1 and B only) or healthy female volunteer (Part A2 only). 2. Aged 18 ‐ 45 years (at [first] dosing). 3. A BMI (Quetelet index) in the range 18.0 ‐ 31.0 kg/m² 4. Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial. 5. Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or their delegate. 6. Agree to follow the contraception requirements of the trial as described in the protocol/ICF. 7. Agree not to donate blood or blood products during the study and for up to 3 months after the administration of th