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A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BAL2420 in Healthy Adult Subjects
Sponsor: Basilea Pharmaceutica
Summary
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.
Official title: A First-in-Human, Randomized, Dose-escalation, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, and Pharmacokinetics of BAL2420 Administered to Healthy Adult Subjects
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2026-03-04
Completion Date
2027-06
Last Updated
2026-03-30
Healthy Volunteers
Yes
Conditions
Interventions
BAL2420 or placebo
Single ascending dose administration (SAD)
BAL2420 or placebo
Multiple-ascending dose (MAD)
BAL2420 or placebo
MAD
Locations (1)
ICON Early Clinical & Bioanalytical Solutions
Groningen, Netherlands