A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BAL2420 in Healthy Adult Subjects

Inclusion criteria

• Body mass index: 18.0 to 30.0 kg/m2, inclusive, at screening
• Total body weight: > 50 kg at screening

Exclusion criteria

• Any uncontrolled or active major systemic disease,
• Active infection
• Acute illness within 5 days prior to the first study drug administration that, in the opinion of the Investigator, may impact safety assessments.
• Clinically-significant physical examination, vital signs, laboratory safety tests, or ECG abnormalities
• History of risk factors for QT prolongation or Torsades de Pointes
• QTcF (Fridericia's corrected QT interval) > 450 msec (males) and > 470 msec (females) at screening.
• Receipt of prescribed medication other than hormonal contraceptives within the 30 days prior to admission to the clinical site.
• Receipt of over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) within 14 days prior to admission to the clinical site.
• History of relevant drug and/or food allergies, particularly to antibiotics.
• History of tobacco use or e-cigarette within the past 6 months prior to the first study drug administration.
• History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 12 months prior to screening.
• Average intake of more than 24 units of alcohol per week: one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
• Positive screen for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibodies, human immunodeficiency virus 1 and 2 antibodies, or syphilis at screening. Note: Hepatitis B vaccination is allowed.