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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: BAL2420 or placebo; Drug: BAL2420 or placebo; Drug: BAL2420 or placebo

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Thomas Kaindl, MD; Phone Number: +41615671505; Email: thomas.kaindl@basilea.com

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • Recruiting
    • ICON Early Clinical & Bioanalytical Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A; A single intravenous (IV) dose of BAL2420 or placebo will be administered to healthy subjects	Drug: BAL2420 or placebo; Single ascending dose administration (SAD); Drug: BAL2420 or placebo; Multiple-ascending dose (MAD); Drug: BAL2420 or placebo; MAD
Experimental: Part B; A daily IV dose of BAL2420 or placebo will be administered multiple times to healthy subjects	Drug: BAL2420 or placebo; Single ascending dose administration (SAD); Drug: BAL2420 or placebo; Multiple-ascending dose (MAD); Drug: BAL2420 or placebo; MAD
Experimental: Part C; A different IV dosing regimen of BAL2420 or placebo will be administered to healthy subjects	Drug: BAL2420 or placebo; Single ascending dose administration (SAD); Drug: BAL2420 or placebo; Multiple-ascending dose (MAD); Drug: BAL2420 or placebo; MAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Basilea Pharmaceutica
• Collaborators: CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator)
• Investigators: Study Director: Thomas Kaindl, MD, Basilea Pharmaceutica International Ltd, Allschwil

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Healthy adults; Antibacterial agent; BAL2420; BAL0302420
• Other Study ID Numbers: BAL2420-CP-101; 75A50122C00028 (Other Grant/Funding Number: HHS/BARDA OTA Number); 2025-523108-59-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No