Actively Recruiting
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
Led by BioVersys SAS · Updated on 2026-05-12
16
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of multiple doses of BV100 on the pharmacokinetics (how the body processes) of polymyxin B in healthy adult volunteers. This open-label, Phase I clinical study focuses on understanding how these two drugs interact when given together. BV100 is an intravenous form of rifabutin being developed to treat serious infections caused by Acinetobacter baumannii, while polymyxin B is an antibiotic used for severe infections from Gram-negative bacteria. Participants will be divided into two sequential groups of eight each. In the first period, all participants receive a single 50 mg intravenous dose of polymyxin B. In the second period, BV100 is given as a 300 mg intravenous infusion every 12 hours for three days, totaling six doses. On the fourth day of the second period, participants receive both BV100 and polymyxin B together in the same infusion bag. The two groups differ by the volume of saline used to dilute the infusions: one group receives 500 mL, the other 250 mL. Participants will be closely monitored throughout the study with assessments including safety evaluations and pharmacokinetic measurements over 96 hours to see how BV100 affects polymyxin B levels. Safety of both drugs alone and in combination will be observed for 27 days. The total participation duration includes screening, two treatment periods, and follow-up to ensure detailed evaluation of drug effects and participant well-being.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and follow instructions during the study
- Signed informed consent
- Male participants aged 18 to 55 years
- Female participants aged 18 to 55 years who are non-childbearing potential and non-lactating, defined as menopausal for 24 months if 50 or older, surgically sterilized, hysterectomy, or premature ovarian failure
- Weight within a body mass index (BMI) range of 19.0 to 30.0 kg/m2
- Estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73 m2
You will not qualify if you...
- Unwilling or unable to give informed consent
- Considered unfit for the study by the study physician after medical screening
- Male participants with female partners who are lactating or pregnant
- Known or suspected allergy to rifabutin or similar drugs including rifampicin, rifapentine, rifaximin
- Known or suspected allergy to polymyxin B or colistin
- History of allergic reactions requiring hospitalization or other significant allergies considered risky by the investigator
- History of antibiotic-associated diarrhea within the last year
- ECG abnormalities such as certain heart blocks, QTcF > 450 ms, PR > 210 ms, or QRS duration > 110 ms
- Abnormal blood pressure or pulse rate outside specified ranges at screening or dosing day
- Clinically relevant abnormal blood cell counts or liver and kidney function tests at screening
- Other lab test values outside reference ranges unless deemed minor and not clinically significant by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 days
Participants receive a single 50 mg IV dose of polymyxin B on Period 1 Day 1, followed by multiple doses of BV100 administered every 12 hours from Day 1 to Day 3. On Period 2 Day 4, participants receive a combined infusion of BV100 and polymyxin B.
Daily visits for 4 days (in-person)
Duration - Up to 27 days
Participants are monitored for safety after completing the treatment.
Periodic safety assessments during follow-up visits
Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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