A Phase 1 Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Polymyxin B in Healthy Volunteers

The primary objective of this phase 1 study is to evaluate the effect of BV100 on the pharmacokinetics of polymyxin B. This assessment is clinically relevant for understanding drug-drug interactions and optimizing dosing regimens for the treatment of infections caused by Acinetobacter baumannii in healthy volunteers.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females, within the 18-44 years age range. The trial is intended for the treatment of infections caused by Acinetobacter baumannii.

This Phase 1 clinical trial is designed to evaluate the effect of BV100 on the pharmacokinetics of polymyxin B in healthy volunteers. The study methodology involves a structured sequence of assessments beginning with a screening visit to determine eligibility. Following screening, participants will undergo study visits to monitor the administration and metabolic processes of the investigational product. The study includes follow-up visits and concludes with an end-of-study visit. The total duration of participant involvement is determined by the protocol-defined visit schedule. Early termination from the study may occur based on predefined clinical criteria or safety protocols.

The efficacy of the intervention in the treatment of Acinetobacter baumannii infections will be evaluated through specified clinical endpoints. Assessment protocols are designed to monitor the response to treatment within the framework of this Phase 3 clinical trial.