A PHASE I OPEN-LABEL RANDOMIZED CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A4+

INTERVENTION: Sixty (60) healthy volunteers, divided into three experimental groups composed of 20 subjects, will be assessed and will receive A4+ for 30 days as follows: Study Group 1 (750 mg: one tablet of 250 mg every 8 hours), Study Group 2 (1500 mg: two tablets of 250 mg every 8 hours), and Study Group 3 (2250 mg: three tablets of 250 mg every 8 hours) CONDITION: ‐K73 PRIMARY OUTCOME: Incidence and severity of adverse events in all enrolled subjects as well as by treatment groups.; NAME OF THE RESULT: ‐ Overall and by group incidence of any adverse event; ‐ Overall and by group incidence of any adverse event by system; ; USED MEASURING METHOD :Incidence of events; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 30 days SECONDARY OUTCOME: Incidence of severe adverse events in all enrolled subjects as well as by treatment groups. ; NAME OF THE RESULT: ‐ Overall and by group incidence of any severe adverse event ; ‐ Overall and by group incidence of any severe adverse event by system ; USED MEASURING METHOD :Incidence ; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE SECONDARY RESULT: 30 days INCLUSION CRITERIA: • Adult volunteers considered to be healthy according to medical and laboratory tests to be performed 10 days before the study start. • Volunteers signing the informed consent form to take part in the clinical trial. • Volunteers agreeing to follow recommendations on their life style by the clinical trial evaluating team for 3 months. • Volunteers accepting to use a contraceptive method (which does not interfere with the research study), as recommended by the principal investigator.