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RecruitingNCT07500181Updated Sep 14, 2026

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

A Phase 1 interventional study of BAL2420 or placebo and BAL2420 or placebo in Healthy, sponsored by Basilea Pharmaceutica. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Basilea Pharmaceutica · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

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.

02

Conditions studied

  • Healthy

Keywords

  • BAL2420
  • BAL0302420
  • Antibacterial agent
  • Pharmacokinetics
  • Healthy adults
03

In context

Lead sponsor

Basilea Pharmaceutica is the lead sponsor of 56 studies on the registry; 5 are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 15 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
136 participants (estimated)

Study arms

  • Experimental
    Part A

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

    Drug: BAL2420 or placebo

  • Experimental
    Part B

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

    Drug: BAL2420 or placebo

  • Experimental
    Part C

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

    Drug: BAL2420 or placebo

Interventions

  • DrugBAL2420 or placebo

    Single ascending dose administration (SAD)

  • DrugBAL2420 or placebo

    Multiple-ascending dose (MAD)

  • DrugBAL2420 or placebo

    MAD

06

What researchers measure

Primary outcomes

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

    Time frame: From screening until Day 10

  2. Number of participants with abnormal electrocardiograms QT Interval in Part A

    Time frame: From screening until Day 10

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

    Time frame: From screening until Day 14

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

    Time frame: From screening until Day 14

07

Study locations

1 of 1 sites recruiting
  • ICON Early Clinical & Bioanalytical Solutions
    Groningen, 9728 NZ, Netherlands
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07500181
Lead sponsor
Basilea Pharmaceutica
Collaborators
German Federal Ministry of Education and Research, Italian Ministry of Economy and Finance, Health Emergency Preparedness and Response Authority, Novo Nordisk Foundation, Wellcome Trust 224842/Z/21/Z, Wellcome Trust 325026/Z/25/Z
Responsible party
Sponsor
First posted
Mar 30, 2026
Start date
Mar 4, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Thomas Kaindl, MD
Contact
thomas.kaindl@basilea.com
+41615671505
Thomas Kaindl, MD
study director · Basilea Pharmaceutica International Ltd, Allschwil

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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