RecruitingPhase 1

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

Austria16 participantsStarted 2026-03-22

Plain-language 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).

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants who were able to understand and follow instructions during the study.
. Participants who signed informed consent.
. Male participants ≥ 18 and ≤ 55 years of age; female participants ≥ 18 and ≤ 55 years of age of non-childbearing potential and non-lactating, with absence of childbearing potential defined as follows:
. 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
. Female participants who underwent hysterectomy
. Female participants with documented premature ovarian failure
. Weight within a BMI range of 19.0 - 30.0 kg/m2.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the effect of repeated doses of intravenous (IV) BV100 on the pharmacokinetics (PK) of polymyxin B

Timeframe: 96 hours

Trial details

NCT IDNCT07580586

SponsorBioVersys SAS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

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