Phase I Open-label Study to Assess the Effects of BV100 on Polymyxin B in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the effect of multiple doses of BV100 on the pharmacokinetics how the body processes of polymyxin B in healthy adult volunteers. This open-label, Phase I clinical study focuses on understanding how these two drugs interact when given together. BV100 is an intravenous form of rifabutin being developed to treat serious infections caused by Acinetobacter baumannii, while polymyxin B is an antibiotic used for severe infections from Gram-negative bacteria. Participants will be divided into two sequential groups of eight each. In the first period, all participants receive a single 50 mg intravenous dose of polymyxin B. In the second period, BV100 is given as a 300 mg intravenous infusion every 12 hours for three days, totaling six doses. On the fourth day of the second period, participants receive both BV100 and polymyxin B together in the same infusion bag. The two groups differ by the volume of saline used to dilute the infusions one group receives 500 mL, the other 250 mL. Participants will be closely monitored throughout the study with assessments including safety evaluations and pharmacokinetic measurements over 96 hours to see how BV100 affects polymyxin B levels. Safety of both drugs alone and in combination will be observed for 27 days. The total participation duration includes screening, two treatment periods, and follow-up to ensure detailed evaluation of drug effects and participant well-being.

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