Clinical trials

2

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Condition / disease
Location
Status: Recruiting

A Single Centre, Open-label, 2-period Fixed-sequence, Phase I Clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Polymyxin B in Healthy Volunteers

This is an open-label, fixed sequence Phase I clinical study to evaluate the effect of multiple doses of BV100 on the PK of polymyxin B in healthy participants (HPs).

Participants needed: 16
Trial details
Phase: Phase 1Age: 18-55Biological sex: AllType: InterventionalSponsor: BioVersys SASUpdated: May 12, 2026Locations: 1
Eligibility criteria

Participants who were able to understand and follow instructions during the stud... [+7]

Unwilling or unable to give informed consent. [+11]

Status: Recruiting

Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex

This is a two-part study, with Part A being the randomized, controlled portion of the study in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). Part B is the single-group portion of the study and includes patients with HABP or VABP with CRABC infections that are resistant to or have failed colistin/polymyxin B treatment.

Participants needed: 248
Trial details
Phase: Phase 3Age: 18-82Biological sex: AllType: InterventionalSponsor: BioVersys SASUpdated: May 4, 2026Locations: 1
Eligibility criteria

Provide written informed consent prior to any study related procedures not part... [+7]

For Part A only, patients with an infection known to be resistant to colistin, w... [+33]