Actively Recruiting
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
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 study instructions
- Signed informed consent
- Male participants aged 18 to 55 years
- Female participants aged 18 to 55 years who are not of childbearing potential and not lactating, defined as postmenopausal for 24 months without recent hormone therapy, surgically sterilized, hysterectomy, or premature ovarian failure
- Body mass index (BMI) between 19.0 and 30.0 kg/m2
- Estimated glomerular filtration rate (eGFR) greater than 60 mL/min/1.73 m2 by MDRD formula
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 pregnant or lactating
- Known or suspected allergy to rifabutin, rifampicin, rifapentine, rifaximin, polymyxin B, or colistin
- History of serious allergic reactions requiring hospitalization or other significant allergic conditions including drug allergies, asthma, eczema, or anaphylaxis (excluding untreated, asymptomatic seasonal allergies)
- History of antibiotic-associated diarrhea within the past year
- ECG abnormalities including second-degree Mobitz II or third-degree heart block, QTcF > 450 ms, PR > 210 ms, or QRS duration > 110 ms
- Abnormal blood pressure outside 95-150 mmHg systolic or 45-95 mmHg diastolic, or pulse rate outside 40-110 bpm at screening or prior to dosing
- Clinically relevant abnormal white blood cell counts, neutrophils, or lymphocytes outside normal ranges
- Clinically significant abnormal liver enzymes (ALT, AST, ALP) or creatinine above normal limits
- Other laboratory test abnormalities exceeding reference ranges unless minor and not clinically significant
AI-Screening
AI-Powered Screening
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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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