NCT07500181

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BAL2420 in Healthy Adult Subjects

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BAL2420 or placebo	Single ascending dose administration (SAD)
DRUG	BAL2420 or placebo	Multiple-ascending dose (MAD)
DRUG	BAL2420 or placebo	MAD

Timeline

• Start date: 2026-03-04
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: Netherlands