Phase 1b Study to Evaluate Safety and Effectiveness of Intravenous BSG005 in Adults with Invasive Fungal Infection Using Dose Escalation

What this Trial Is About

Researchers are evaluating intravenous BSG005 in patients with uncomplicated invasive fungal infections IFI in an open-label Phase 1b study. This single-arm, dose-escalation trial aims to assess the safety and efficacy of BSG005, enrolling approximately 15 patients in three cohorts. The study includes a Screening period, Treatment period, and Follow-up period, focusing on patients with IFI who may have failed or cannot tolerate first-line antifungal treatments. BSG005 will be administered daily via intravenous infusion over 120 minutes which may be extended to 240 minutes, with doses escalating depending on safety and efficacy assessments. Treatment starts at 0.1 mgkg in Cohort 1, increasing up to 1.0 mgkg over a maximum of 28 days. Subsequent cohorts may receive higher maximum doses up to 3.0 mgkg, adjusted by the investigator based on patient status. Central or long peripheral catheters are preferred due to the drugs potential for causing phlebitis. Participants will be in the study for up to 50 days, including a 7-day Screening period, baseline assessments, up to 28 days of treatment, and a 14-day follow-up. Researchers will monitor safety, tolerability, and overall response to treatment through clinical, mycological, and radiological evaluations. The primary outcome is to establish the safety and tolerability of BSG005, with secondary outcomes assessing treatment response during and after therapy.

Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection