A study to evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect of MRX-5 Tablets in Healthy Adult Subjects

Exclusion Criteria22

• Female subjects must be non-pregnant and non-lactating.
• Female subjects must be of non-childbearing potential, or agree to use an acceptable method(s) of contraception and must not donate any eggs from signing ICF and for at least 90 days after the last dosing, and have negative pregnancy test results at Screening (serum) and Admission (urine).
• Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) in addition to an acceptable barrier method (female partner) of contraception and must not donate sperm from signing ICF and for at least 90 days after the last dosing.
• Capable of giving signed informed consent which includes compliance with the schedule, requirements, and restrictions of the study.
• Use of tobacco or nicotine products more than 5 units/week, in any form, within 30 days prior to study drug administration on Day 1.
• Routine consumption of prescription within 14 days prior to study drug administration on Day 1 or consumption of over-the-counter [OTC] medication, vitamin, mineral, grapefruit, or dietary supplement within 7 days prior to study drug administration.
• Blood pressure (BP) greater than 140/90 mmHg or below 85/40 mmHg (seated). BP out of range may be allowed if considered not clinically significant by the Investigator.
• History of drug or alcohol abuse in the previous 2 years (Defined excessive alcohol intake as regular consumption over 14 units per week [female] or 21 units per week [male] at least).
• Positive pre-study drug or alcohol & smoking screen on Day-1.
• Positive test results for hepatitis B surface antigen, antibody to hepatitis B core antigen, hepatitis C virus antibody, anti–HIV type 1 antibody, and COVID-19.
• Any history of allergic drug reactions; exceptions may be granted on a case-by-case basis upon agreement of the PI and the Medical Monitor.
• History of vaccination within 30 days prior to study drug administration on Day 1, or have vaccination intentions during the study or within 30 days end of the study.
• Any clinical suggestion or family history of renal disease such as polycystic kidney disease, medullary sponge kidney, glomerulonephritis, or any other significant renal symptoms and signs such as clinically significant hematuria, pyuria, proteinuria, glycosuria, and or pathologic crystals findings in the urinalysis.
• Administration of another investigational medication within 30 days (or 5 half-lives, whichever is longer) prior to study drug administration.
• Participation in an investigational device study within 30 days prior to study drug administration.
• Venous access considered inadequate for PK sample collection.
• Any condition that might interfere with study drug absorption or elimination, such as hepato-biliary disease, surgery of the small intestine, cholecystectomy, or gastrointestinal disease (e.g., nausea, vomiting, diarrhea).
• Loss or donation of blood greater than 500 mL, or plasma donation within 30 days prior to study drug administration.
• ECG abnormalities outside of accepted ranges and considered to be clinically significant. Subjects with QTcF greater than 450 msec (if male) or greater than 470 msec (if female) will be excluded.
• Is an employee or family member of the investigator or study site personnel.
• Subjects meeting the following criteria will be excluded from study Part 1, Cohort 7:
• Inability or unwillingness to consume a standard high-fat meal, as described in FDA Guidance for fed vs. fasted PK studies