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 who were able to understand and follow instructions during the study.
Participants who signed informed consent.
Female participants 50 years of age or older, in menopause for 24 consecutive months and not receiving any hormone replacement therapy within 24 months prior to inclusion into the study
Female participants who underwent surgical sterilization
Unwilling or unable to give informed consent.
As a result of the medical screening process, the study physician considered the participant unfit for the study.
Male participants with female partners who are lactating or pregnant.
Known or suspected history of hypersensitivity to rifabutin or to drugs of a similar chemical class including rifampicin, rifapentine, rifaximin.
Single group
BV100 (300 mg)
Drug300 mg BV100 infused over 2 hours every 12 hours (q12h)
Polymyxin B (50 mg)
Drug500,000 IU (50 mg) polymyxin B infused over 2 hours
To evaluate the effect of repeated doses of intravenous (IV) BV100 on the pharmacokinetics (PK) of polymyxin B
Area under the curve (AUC) for polymyxin B in the presence and absence of BV100
To investigate the safety of BV100 and polymyxin B when administered alone or in combination
The incidence, nature, and severity of treatment-emergent adverse events (TEAEs), related to single IV doses of polymyxin B, assessed following its IV administration with and without BV100. The incidence, nature, and severity of TEAEs related to IV administration of BV100.
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