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

NCT07500181 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-09-14

No results posted yet for this study

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

DRUG

BAL2420 or placebo

Single ascending dose administration (SAD)

DRUG

BAL2420 or placebo

Multiple-ascending dose (MAD)

DRUG

BAL2420 or placebo

MAD

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Italian Ministry of Economy and Finance

    collaborator UNKNOWN

  • Health Emergency Preparedness and Response Authority

    collaborator UNKNOWN

  • Novo Nordisk Foundation

    collaborator OTHER

  • Wellcome Trust 224842/Z/21/Z

    collaborator UNKNOWN

  • Wellcome Trust 325026/Z/25/Z

    collaborator UNKNOWN

  • Basilea Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Thomas Kaindl, MD · Basilea Pharmaceutica International Ltd, Allschwil

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-04
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07500181 on ClinicalTrials.gov