Condition: Invasive Fungal Infection · Sponsor: Biosergen AS
This study is an open-label, Phase 1b, dose-escalation/finding study to assess the safety and efficacy of intravenous BSG005 in patients with uncomplicated invasive fungal infections (IFI). Approximately 15 patients are planned to be enrolled in 3 cohorts. The study will be conducted in 3 cohorts consisting of 3 periods, namely: Screening, Treatment, and Follow-up periods. In each cohort, 5 patients are planned to be enrolled. This study is a single-arm study. The treatment (BSG005) in each dose level will be administered once daily for 3 days via IV infusion. If the safety and tolerability profiles are acceptable at each dose level, the patients will be treated for a maximum of 28 days. Each patient will be in the study for up to 50 days, which consists of a 7-day Screening period, 1 day for baseline assessments, up to 28 days (maximum) of treatment with BSG005, and 14 days of follow-up.
This description comes directly from the study's public registry record.
Tine Olesen, CEO · +4531355707 · tine.olesen@biosergen.net
Niels Laursen, CFO · +4540145059 · niels.laursen@biosergen.net
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| JSS Medical Research Asia Pacific Private Limited | Dehli, Haryana, India | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06678113