Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07500181 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Collaborators: 1 to 6v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07500181
Lead Sponsor Basilea Pharmaceutica
Collaborators: German Federal Ministry of Education and Research, Italian Ministry of Economy and Finance, Health Emergency Preparedness and Response Authority, Novo Nordisk Foundation, Wellcome Trust 224842/Z/21/Z, Wellcome Trust 325026/Z/25/Z
Conditions
(from sponsor)		 Healthy
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov