A Single Centre, Open-label, 2-period Fixed-sequence, Phase I Clinical Study to Evaluate t
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).
| Condition(s) | Healthy Adult Participants |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 | 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 f |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | BioVersys SAS |
| Locations | Vienna, Austria |
| Start date | 2026-03-22 |
| NCT ID | NCT07580586 |
| Official listing | https://clinicaltrials.gov/study/NCT07580586 |