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

Recruiting Phase 1 Interventional Study
Healthy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
136 (estimated)
Sponsor
Basilea Pharmaceutica · Industry
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About This Trial
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 a…
Trial Locations
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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…
Contacts

Thomas Kaindl, MD

+41615671505

thomas.kaindl@basilea.com

CONTACT