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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07500181

Enrollment

136

Registered

2026-03-30

Start date

2026-03-04

Completion date

2027-06-01

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

BAL2420, BAL0302420, Antibacterial agent, Pharmacokinetics, Healthy adults

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.

Interventions

DRUGBAL2420 or placebo

Single ascending dose administration (SAD)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Netherlands

Contacts

CONTACTThomas Kaindl, MD

thomas.kaindl@basilea.com+41615671505

STUDY_DIRECTORThomas Kaindl, MD

Basilea Pharmaceutica International Ltd, Allschwil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026