drugset / Trial / NCT07580586

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

NCT07580586

Phase 1 Recruiting 16 enrolled BioVersys SAS
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2026-03-22
Primary completion
2026-09-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Polymyxin B Peptide 50 mg Intravenous
Subject Rifabutin Small molecule 300 mg Intravenous

Indications

No indication recorded.