Actively Recruiting
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BAL2420 in Healthy Adult Subjects
Led by Basilea Pharmaceutica · Updated on 2026-03-30
136
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
Sponsors
B
Basilea Pharmaceutica
Lead Sponsor
C
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BAL2420 in Healthy Adult Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index between 18.0 and 30.0 kg/m2 at screening
- Total body weight greater than 50 kg at screening
- Age between 18 and 55 years
You will not qualify if you...
- Any uncontrolled or active major systemic disease
- Active infection
- Acute illness within 5 days prior to first study drug administration
- Clinically significant abnormalities in physical exam, vital signs, laboratory tests, or ECG
- History of risk factors for QT prolongation or Torsades de Pointes
- QTcF greater than 450 msec (males) or 470 msec (females) at screening
- Use of prescribed medication other than hormonal contraceptives within 30 days prior to admission
- Use of over-the-counter medications, vitamins, supplements, or herbal medications within 14 days prior to admission
- History of drug or food allergies, especially to antibiotics
- Tobacco or e-cigarette use within 6 months prior to first study drug administration
- History of alcohol abuse or drug addiction within 12 months prior to screening
- Average alcohol intake exceeding 24 units per week
- Positive screening for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibodies, HIV 1 or 2 antibodies, or syphilis at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ICON Early Clinical & Bioanalytical Solutions
Groningen, Netherlands, 9728 NZ
Actively Recruiting
Research Team
T
Thomas Kaindl, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here