BAL2420 (also known as BAL0302420) is being developed as an antibacterial agent for the treatment of severe infections caused by Gram-negative bacteria. In this study, the sponsor aims to investigate the safety, tolerability and pharmacokinetics (PK) of BAL2420 following administration of single ascending doses (Part A) and multiple ascending doses (Parts B and C) in healthy adult volunteers. In all parts of the study, in each cohort, a different dose of study drug is to be investigated against a matched placebo in a randomized and double-blind manner.
Body mass index: 18.0 to 30.0 kg/m2, inclusive, at screening
Total body weight: > 50 kg at screening
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
Basilea Pharmaceutica
Lead sponsor
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator)
Collaborator