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 | Recruiting Phase 1

• 2 other identifiers: BV100-0112026-525542-30-00
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Area under the curve (AUC) for polymyxin B in the presence and absence of BV100

  96 hours

Secondary Outcomes (1)

• To investigate the safety of BV100 and polymyxin B when administered alone or in combination

  27 days

Study Arms (1)

BV100 plus Polymyxin B

EXPERIMENTAL

Drug: BV100 (300 mg); Drug: Polymyxin B (50 mg)

Interventions

BV100 (300 mg) DRUG

300 mg BV100 infused over 2 hours every 12 hours (q12h)

BV100 plus Polymyxin B

Polymyxin B (50 mg) DRUG

500,000 IU (50 mg) polymyxin B infused over 2 hours

BV100 plus Polymyxin B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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.
• Estimated glomerular filtration rate (eGFR) according to the MDRD formula : \> 60 mL/min/1.73 m2.

You may not qualify if:

• 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.
• Male participants with female partners who are lactating or pregnant.
• Known or suspected history of hypersensitivity to rifabutin or to drugs of a similar chemical class including rifampicin, rifapentine, rifaximin.
• Known or suspected history of hypersensitivity to polymyxin B or colistin.
• 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.
• History of antibiotic associated diarrhoea within the last year.
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• BioVersys SAS: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Interventions

Polymyxin B

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 12, 2026
• Study Start: March 22, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

AU (1)