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RECRUITING
NCT07500181
PHASE1

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

Sponsor: Basilea Pharmaceutica

View on ClinicalTrials.gov

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

DRUG

BAL2420 or placebo

Single ascending dose administration (SAD)

DRUG

BAL2420 or placebo

Multiple-ascending dose (MAD)

DRUG

BAL2420 or placebo

MAD

Locations (1)

ICON Early Clinical & Bioanalytical Solutions

Groningen, Netherlands