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.
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