A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MRX-I Tablets in Healthy Adult Subjects (Part 3)

INTERVENTION: Part 3 has a double‐blind, comparative, double‐dummy, two cohort design. This part of the study will enroll 12 subjects in each of two cohorts (total of 24 subjects). Subjects will be screened and then randomized in parallel to receive either oral MRX‐I (800mg) or oral linezolid (600mg). Both will be administered once every 12 hours for 28 days. Subjects will be confined in a Clinical Research Unit during the dosing periods and will be monitored to ensure compliance with dosing. CONDITION: This study is for healthy volunteers. The intended use of the investigational product is the treatment of serious gram‐positive bacterial infections PRIMARY OUTCOME: Safety and tolerability as assessed through the determination and recording of the occurrence of AEs as well as by adverse changes in vital signs, ECG (e.g. QTc interval) parameters, and laboratory data. SECONDARY OUTCOME: To determine the pharmacokinetics of MRX‐I as assessed through blood and urine collection during the study INCLUSION CRITERIA: This study will be conducted in normal, healthy, adult, male or female non‐Chinese subjects aged between 18‐50 years and with a BMI greater than or equal to 18 and less than or equal to 32. Eligible subjects will be in good health without signs or symptoms of current illness and with predose clinical and laboratory examinations without clinically significant findings.