RecruitingPhase 1NCT07500181

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

Sponsor

Basilea Pharmaceutica

Enrollment

136 participants

Start Date

Mar 4, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria2

Body mass index: 18.0 to 30.0 kg/m2, inclusive, at screening
Total body weight: > 50 kg at screening

Exclusion Criteria13

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.