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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

NCT07580586 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-05-12

No results posted yet for this study

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).

Conditions

  • Healthy Adult Participants

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

Sponsors & Collaborators

  • BioVersys SAS

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-22
Primary Completion
2026-09-30
Completion
2026-12-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07580586 on ClinicalTrials.gov