NCT07500181

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P75+ for phase_1 healthy

Timeline
12mo left

Started Mar 2026

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Mar 2026Jun 2027

Study Start

First participant enrolled

March 4, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 18, 2026

Last Update Submit

March 24, 2026

Conditions

Healthy

Keywords

BAL2420BAL0302420Antibacterial agentPharmacokineticsHealthy adults

Outcome Measures

Primary Outcomes (4)

  • Number of participants reporting adverse events (AEs) in Part A

    From screening until Day 10

  • Number of participants with abnormal electrocardiograms QT Interval in Part A

    From screening until Day 10

  • Number of participants reporting adverse events (AEs) in Part B and C

    From screening until Day 14

  • Number of participants with abnormal ECG QT Interval in Part B and C

    From screening until Day 14

Study Arms (3)

Part A

EXPERIMENTAL

A single intravenous (IV) dose of BAL2420 or placebo will be administered to healthy subjects

Drug: BAL2420 or placebo

Part B

EXPERIMENTAL

A daily IV dose of BAL2420 or placebo will be administered multiple times to healthy subjects

Drug: BAL2420 or placebo

Part C

EXPERIMENTAL

A different IV dosing regimen of BAL2420 or placebo will be administered to healthy subjects

Drug: BAL2420 or placebo

Interventions

BAL2420 or placeboDRUG

Single ascending dose administration (SAD)

Part A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index: 18.0 to 30.0 kg/m2, inclusive, at screening
  • Total body weight: \> 50 kg at screening

You may not qualify if:

  • Any uncontrolled or active major systemic disease,
  • Active infection
  • Acute illness within 5 days prior to the first study drug administration that, in the opinion of the Investigator, may impact safety assessments.
  • Clinically-significant physical examination, vital signs, laboratory safety tests, or ECG abnormalities
  • History of risk factors for QT prolongation or Torsades de Pointes
  • QTcF (Fridericia's corrected QT interval) \> 450 msec (males) and \> 470 msec (females) at screening.
  • Receipt of prescribed medication other than hormonal contraceptives within the 30 days prior to admission to the clinical site.
  • Receipt of over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) within 14 days prior to admission to the clinical site.
  • History of relevant drug and/or food allergies, particularly to antibiotics.
  • History of tobacco use or e-cigarette within the past 6 months prior to the first study drug administration.
  • History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 12 months prior to screening.
  • Average intake of more than 24 units of alcohol per week: one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
  • Positive screen for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibodies, human immunodeficiency virus 1 and 2 antibodies, or syphilis at screening. Note: Hepatitis B vaccination is allowed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON Early Clinical & Bioanalytical Solutions

Groningen, 9728 NZ, Netherlands

RECRUITING

Study Officials

  • Thomas Kaindl, MD

    Basilea Pharmaceutica International Ltd, Allschwil

    STUDY DIRECTOR

Central Study Contacts

Thomas Kaindl, MD

CONTACT

+41615671505thomas.kaindl@basilea.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 30, 2026

Study Start

March 4, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)