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RECRUITING
NCT07580586
PHASE1

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

Sponsor: BioVersys SAS

View on ClinicalTrials.gov

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).

Official title: BV100-011 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2026-03-22

Completion Date

2026-12-30

Last Updated

2026-05-12

Healthy Volunteers

Yes

Interventions

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

Locations (1)

Medical University of Vienna

Vienna, Austria