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

May 5, 2026 updated by: BioVersys SAS

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
          • Markus Zeitlinger, Prof.
          • Phone Number: +43 1 401600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Main Inclusion Criteria:

  1. Participants who were able to understand and follow instructions during the study.
  2. Participants who signed informed consent.

  3. 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:

    1. 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
    2. Female participants who underwent surgical sterilization
    3. Female participants who underwent hysterectomy
    4. Female participants with documented premature ovarian failure
  4. Weight within a BMI range of 19.0 - 30.0 kg/m2.
  5. Estimated glomerular filtration rate (eGFR) according to the MDRD formula : > 60 mL/min/1.73 m2.

Main Exclusion Criteria:

  1. Unwilling or unable to give informed consent.
  2. As a result of the medical screening process, the study physician considered the participant unfit for the study.
  3. Male participants with female partners who are lactating or pregnant.
  4. Known or suspected history of hypersensitivity to rifabutin or to drugs of a similar chemical class including rifampicin, rifapentine, rifaximin.
  5. Known or suspected history of hypersensitivity to polymyxin B or colistin.
  6. History of allergic reactions leading to hospitalization or any other allergic conditions (including drug allergies, asthma, eczema, anaphylactic reactions but excluding untreated, asymptomatic, seasonal allergies) which the Investigator considers may affect the safety of the participant and/or outcome of the study.
  7. History of antibiotic associated diarrhoea within the last year.
  8. Participants with ECG abnormalities (history, or evidence of second-degree heart block of Mobitz type II, third degree heart block, or any abnormality considered relevant by the Investigator), QTcF > 450 ms, PR > 210 ms, or QRS duration > 110 ms.
  9. Supine systolic blood pressure > 150 mmHg or < 95 mmHg or diastolic blood pressure > 95 mmHg or < 45 mmHg at Screening or Period 1 Day 1 prior to dosing (any clinically relevant abnormal blood pressure results may be repeated once and if the repeat result is within the normal range, it is not considered to have met the exclusion criterion). Pulse rate > 110 or < 40 beats per minute at Screening or Period 1 Day 1 prior to dosing.
  10. Clinically relevant abnormal values for leukocytes (total WBC), neutrophils, and lymphocytes (total), above the upper level of normal (ULN) or below the lower limit of normal (LLN) at screening, at the Investigator's discretion. Any clinically relevant abnormal value of these parameters may be repeated during screening.
  11. Clinically relevant abnormal values for Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and creatinine, above the ULN at Screening, at the Investigator's discretion. Any clinically relevant abnormal value of these parameters may be repeated during screening.
  12. Screening laboratory test values other than AST, ALT, ALP, creatinine, leucocytes, lymphocytes or neutrophils for haematology, biochemistry, or urinalysis must not exceed the reference range. Minor deviations from normal are allowed, if they are not considered clinically significant by the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BV100 plus Polymyxin B
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the effect of repeated doses of intravenous (IV) BV100 on the pharmacokinetics (PK) of polymyxin B
Time Frame: 96 hours
Area under the curve (AUC) for polymyxin B in the presence and absence of BV100
96 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To investigate the safety of BV100 and polymyxin B when administered alone or in combination
Time Frame: 27 days

The incidence, nature, and severity of treatment-emergent adverse events (TEAEs), related to single IV doses of polymyxin B, assessed following its IV administration with and without BV100.

The incidence, nature, and severity of TEAEs related to IV administration of BV100.
27 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioVersys SAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BV100-011
  • 2026-525542-30-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Still to be discussed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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