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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
136
Single ascending dose administration (SAD)
Multiple-ascending dose (MAD)
MAD
ICON Early Clinical & Bioanalytical Solutions
Groningen, Netherlands
RECRUITINGNumber of participants reporting adverse events (AEs) in Part A
Time frame: From screening until Day 10
Number of participants with abnormal electrocardiograms QT Interval in Part A
Time frame: From screening until Day 10
Number of participants reporting adverse events (AEs) in Part B and C
Time frame: From screening until Day 14
Number of participants with abnormal ECG QT Interval in Part B and C
Time frame: From screening until Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.