NCT07500181 A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BAL2420 in Healthy Adult Subjects
| NCT ID | NCT07500181 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Basilea Pharmaceutica |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2026-03-04 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 136 participants in total. It began in 2026-03-04 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Thomas Kaindl, MD
STUDY DIRECTOR
Basilea Pharmaceutica International Ltd, Allschwil
Frequently Asked Questions
Who can join the NCT07500181 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07500181 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07500181 currently recruiting?
Yes, NCT07500181 is actively recruiting participants. Contact the research team at thomas.kaindl@basilea.com for enrollment information.
Where is the NCT07500181 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT07500181 clinical trial?
NCT07500181 is sponsored by Basilea Pharmaceutica. The principal investigator is Thomas Kaindl, MD at Basilea Pharmaceutica International Ltd, Allschwil. The trial plans to enroll 136 participants.