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
Parallel
BAL2420 or placebo
DrugSingle ascending dose administration (SAD)
BAL2420 or placebo
DrugMultiple-ascending dose (MAD)
BAL2420 or placebo
DrugMAD
Number of participants reporting adverse events (AEs) in Part A
Number of participants with abnormal electrocardiograms QT Interval in Part A
Number of participants reporting adverse events (AEs) in Part B and C
Number of participants with abnormal ECG QT Interval in Part B and C
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Basilea Pharmaceutica
Lead sponsor
German Federal Ministry of Education and Research
Collaborator
Italian Ministry of Economy and Finance
Collaborator
Health Emergency Preparedness and Response Authority
Collaborator
Novo Nordisk Foundation
Collaborator
Wellcome Trust 224842/Z/21/Z
Collaborator
Wellcome Trust 325026/Z/25/Z
Collaborator
