Clinical Trial: 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

U.S., May 13 -- ClinicalTrials.gov registry received information related to the study (NCT07580586) titled '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' on April 28.

Brief 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).

Study Start Date: March 22

Study Type: INTERVENTIONAL

Condition: Healthy Adult Participants

Intervention: DRUG: BV100 (300 mg)

300 mg BV100 infused over 2 hours every 12 hours (q12h)

DRUG: Polymyxin B (50 mg)

500,000 IU (50 mg) polymyxin B infused over 2 hours

Recr...