Evaluation of the Potential Impact of a High-fat Meal on the Pharmacokinetics of CRS3123 in Healthy Adult Participants

Exclusion Criteria

• •1. Any clinically significant abnormal finding at physical examination at screening that may interfere with the interpretation of safety and PK objectives of the study.
• •2. Abnormal laboratory test results (above Grade 1) that may interfere with the interpretation of safety and PK objectives of the study.
• •3. Positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antigen and antibody.
• •4. History of current or chronic liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• •5. Positive pregnancy test at screening or admission to the clinical research unit.
• •6. Positive urine drug screen, urine cotinine test, or alcohol test at screening or admission to the clinical research unit.
• •7. Known allergic reactions to CRS3123 or other related drugs, or to any excipient in the formulation.
• •8. Use of medications within specified timeframes.
• •9. Previous exposure to CRS3123 within 12 months prior to the first dose.
• •10. Participants with HR \< 50 or \> 100 beats per minute (bpm), systolic blood pressure (SBP) \< 90 or \> 140 mmHg, diastolic blood pressure (DBP) \< 50 or \> 90 mmHg, on vital sign assessment at screening or admission to the clinical research unit.
• •11. A baseline ECG at screening with corrected QT interval (QTc) using Fridericia's formula (QTcF) \> 450 msec.
• •12. Evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization). Any clinically significant (above Grade 1) conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular block \[second degree or higher\], Wolf Parkinson White syndrome), sinus pauses \> 3 seconds, non sustained or sustained ventricular tachycardia (≥ 3 consecutive ventricular ectopic beats) or any significant arrhythmia which, in the opinion of the Investigator will interfere with the safety of the individual participant.
• •13. Participant has any surgical or medical condition (active or chronic) or GI tract condition (e.g., surgical resection of significant proportions of the stomach or bowel, gastric bypass, gastric banding, irritable bowel syndrome, inflammatory bowel disease, or any other condition that may interfere with normal gastric emptying or transit time) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the participant at risk, in the opinion of the Investigator.
• •14. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days or 5× t½ (whichever is longer) prior to the first dose, administration of a biological product in the context of a clinical research study within 90 days or 5× t½ (whichever is longer) prior to the first dose or concomitant participation in an investigational study involving no drug or device administration.
• •15. Participants with serum creatinine level \> 1.5 mg/dL.
• •16. History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
• •17. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
• •18. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to first dosing.
• •19. Participant is unable to comply with all the study procedures in the opinion of the Investigator.
• •20. Any reason the participant should not participate in the study in the opinion of the Investigator.