A Phase 1 Study of MAXONA Pharmaceuticals MAX-001 healthy subjects for the selection of an extended release form based on the evaluation of safety, tolerability, and drug concentrations

INTERVENTION: MAX‐001‐101 Stage 1 is a two‐part study within which parts 1 (formulation selection) and 2 (food effect assessment) will be conducted sequentially. Each study part will involve unique participants. Part 1: Formulation Selection Using a cross over design, a total of 12 participants will each receive a single oral administration of each of 3 different formulations of MAX‐001 and single oral administration of the reference formulation. Administered doses of each of the 4 formulations will be 30mg MAX‐001 ER1, 30mg MAX‐001 ER‐2, 30mg MAX‐001 ER‐3 and 30mg IR. The wash‐out period between each single dose administration is 1 week. Healthy volunteers will stay in the clinical research unit for the entire duration of dosing and will take study drug under direct supervision of the clinical research unit staff. Part 2: Food Effect A total of 16 participants will be enrolled across two cohorts to each receive a single oral administration of one or two formulations selected from Part 1 with and without food. The wash‐out period between each single dose administration is 1 week. Each oral administration is to occur either after a 10 hour overnight fast or 30 minutes after the ingestion of a high calorie and high‐fat breakfast. The standardised meal will be the standard US Food and Drug Administration high‐fat, high calorie (800 to 1000 calories) breakfast. Approximately 50% of total caloric content of the meal will be from fat. The meal will derive approximately 150, 250, and 500‐600 calories from protein, carbohydrate, and fat, respectively. Healthy volunteers will stay in the clinical research unit for the entire duration of dosing and will take study drug under direct supervision of the clinical research unit staff. CONDITION: Anaesthesiology ‐ Pain management Various pain indications; ; Various pain indications SECONDARY OUTCOME: Tolerability is assessed by subject as the degree to which adverse effects can be tolerated by the subject (ICH). This information represents the subjective report of the subjects on how they are feeling and functioning during or after exposure to the investigational drug. The subject will report this information to the investigator during the clinical interaction, physical examination, every day while on‐site at the clinical, at every follow‐up visit and follow‐up phone call[Secondary timepoint [1]: Day ‐1 (the day before dosing) to Day 3 (2 days post‐ each dose)] INCLUSION CRITERIA: ‐ able to understand, sign and commit to informed consent and to all study procedures ‐ adhere to effective double‐barrier contraception or in proven post‐menopause ‐ healthy as determined during screening based on medical history, physical examination, vital signs, ECG (QTcF <=450 msec in males, QTcF <=470 in females), and laboratory assessments ‐ Body Mass Inde X18 to 32.0 kg/m2 ‐ Non‐smokers or social smokers (0‐5 cigarettes per month) ‐ Commitment to adhere to lifestyle guidance during the study participation PRIMARY OUTCOME: Primary outcome [1]: Integrated safety evaluation.; Integrated safety evaluation. The safety parameters to be assessed include AEs/SAEs, and changes in clinical laboratory tests, vital signs, 12‐lead ECG, and physical examinations from baseline.; Adverse events will be reported by the participant. The Investigator and any designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. Events meeting the AE definition include:; • Any abnormal laboratory test results (hematology, coagulation, clinical chemistry, or urinalysis) or other safety assessments (eg, ECG, vital signs measurements, or physical examinations), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.; • Exacerbation of a chronic or intermittent pre‐existing condition including either an increase in frequency and/or intensity of the condition.; • New conditions detected or diagnosed after study drug administration although it may have been present before the start of the study.; • Signs, symptoms, or the clinical sequelae of a suspected drug‐drug interaction.; • Signs, symptoms, or the clinical sequelae of a suspected overdose of either study drug or a concomitant medication. Overdose per se will not be reported as an AE/SAE unless it is an intentional overdose taken with possible suicidal/self‐harming intent. Such overdoses should be reported regardless of sequelae. ; Severity categories of AE assessment include mild, moderate, and severe, as defined below‐; • Mild: A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living; • Moderate: A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research subject.; • Severe: A type of adverse event that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.; Vital signs measurements will include tympanic body temperature, pulse rate, and blood pressure. Blood pressure and pulse rate will be assessed with a completely automated device; manual techniques will be used only if an automated device is not available.; [Stage 1: Formulation Selection and Food Effect Assessment: ; Day ‐1 (the day before dosing) to Day 3 (2 days post‐ each dose); Clinical laboratory blood tests will be assessed at Screening and on Day ‐1, Day 1, Day 2, and Day 3.; Clinical laboratory urinalysis will be assessed at Screening and on Day 2 and Day 3.; A complete physical examinations will be assessed at screening, while symptom‐directed physical examinations will be assessed on Day ‐1, Day 1, Day 2 and Day 3..; Vital signs will be assessed at Screening and on Day ‐1, Day 1, Day 2 and Day 3..; 12‐Lead ECG will be assessed at Screening and on Day ‐1, Day 1, Day 2 and Day 3..; AEs/SAEs will be assessed at all timepoints.; ] Primary outcome [2]: Pharmacokinetic profile; • Stage 1 (Formulation Selection Part and Food Effect Assessment Part): Cmax, Cmin, AUCinf, AUClast, Tmax, Tmin, and t ½; [Primary timepoint [2]; • Stage 1 (Formulation and Food Effect): blood samples collected at: pre‐dose,0.25,0.5, 0.75,1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post each dose.; ]