BAL2420 safety and dosing in healthy adults
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
This trial will test how safe BAL2420 is and how the body absorbs and clears different single and repeated doses in healthy adult volunteers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Basilea Pharmaceutica Industry-sponsored |
| Locations | 1 site (Groningen) |
| Trial ID | NCT07500181 on ClinicalTrials.gov |
What this trial studies
Basilea is conducting a randomized, double-blind, placebo-controlled Phase I study of BAL2420 in healthy adult volunteers to characterize safety, tolerability, and pharmacokinetics. Part A uses single ascending doses while Parts B and C use multiple ascending doses, with each cohort randomized to BAL2420 or matched placebo. Serial blood sampling, ECGs, and laboratory safety tests will be used to measure pharmacokinetics and detect adverse events. The study is conducted at an early clinical site in Groningen with sponsorship from Basilea and support from CARB-X.
Who should consider this trial
Good fit: Ideal candidates are healthy adult volunteers who meet entry criteria (for example, BMI 18–30 kg/m2 and body weight >50 kg) and have no active illness, significant medical history, or recent use of excluded medications.
Not a fit: Patients with active infections, significant comorbidities, or those needing immediate antibiotic therapy are unlikely to receive direct clinical benefit from this early safety study.
Why it matters
Potential benefit: If successful, BAL2420 could become a new treatment option for severe infections caused by Gram-negative bacteria, especially where resistance limits current choices.
How similar studies have performed: Testing safety and pharmacokinetics of investigational antibiotics in healthy volunteers is a standard early-phase approach that has supported development of several approved antibacterial drugs, though BAL2420 itself remains investigational.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Groningen
- ICON Early Clinical & Bioanalytical Solutions — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Thomas Kaindl, MD
- Email: thomas.kaindl@basilea.com
- Phone: +41615671505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.