A Phase 1 interventional study of BAL2420 or placebo and BAL2420 or placebo in Healthy, sponsored by Basilea Pharmaceutica. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Basilea Pharmaceutica · Phase 1, Interventional, and Basic science
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.
Basilea Pharmaceutica is the lead sponsor of 56 studies on the registry; 5 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 15 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A single intravenous (IV) dose of BAL2420 or placebo will be administered to healthy subjects
Drug: BAL2420 or placebo
A daily IV dose of BAL2420 or placebo will be administered multiple times to healthy subjects
Drug: BAL2420 or placebo
A different IV dosing regimen of BAL2420 or placebo will be administered to healthy subjects
Drug: BAL2420 or placebo
Single ascending dose administration (SAD)
Multiple-ascending dose (MAD)
MAD
Number 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
Plan to share: No
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Basilea Pharmaceutica