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

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).

BV100 (rifabutin for infusion) is being developed as an IV formulation for the treatment of serious infections due to Acinetobacter baumannii, including nosocomial pneumonia and blood stream infection (BSI).

Polymyxin B for Injection (Polymyxin B sulfate) is a polypeptide antibiotic that is derived from Bacillus polymyxa (more recently termed Paenibacillus polymyxa). Polymyxin B sulfate is an antibiotic often used to treat serious infections due to aerobic Gram-negative pathogens in patients with limited treatment options.

BV100 has shown strong synergy with polymyxin B against carbapenem-resistant A. baumannii (CRAB).

Study participants will be divided into two sequential groups, each consisting of 8 (eight) participants:

* Group 1 will receive all doses of polymyxin B (Period 1), BV100 (Period 2), and the combination of BV100 and polymyxin B (Period 2) diluted in 500 mL sterile 0.9% saline per infusion; and, * Group 2 will receive all doses of polymyxin B (Period 1), BV100 (Period 2), and the combination of BV100 and polymyxin B (Period 2) diluted in 250 mL sterile 0.9% saline per infusion.

Each subject will receive a single 50 mg IV dose of polymyxin B on Period 1 Day 1.

BV100 will be administered as a 300 mg IV infusion every 12 hours in Period 2 from Day 1 to Day 3, totalling 6 doses.

On Period 2 Day 4, 300 mg IV dose of BV100 will be co-administered with a 50 mg IV dose of polymyxin B in the same infusion bag.