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.
Age 18 years.
Able to provide written informed consent or have a legally authorized representative that can provide informed consent in case of incapacitation.
Diagnosed by Investigator to have an IFI.
IFI patients with mild to moderate renal impairment or IFI patients requiring an alternative treatment as current treatment cannot be continued due to any of the following
Patient has a known hypersensitivity or severe infusion-related reaction to any polyene drug.
Infection caused by a known or suspected organism with intrinsic resistance to AmB.
Concurrent use of another investigational agent within 30 days of enrollment.
Chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 30 mL/min or dialysis. Patients with acute kidney injury with eGFR less than 30 mL/min and improving creatinine level can be included as judged by the Investigator.
Single group
BSG005
DrugSingle arm dose escalation in patients with invasive fungal infection
To establish the safety and tolerability of BSG005 in patients with severe invasive fungal infection
Treatment Emergent Adverse Event (CTC grading of severity)
To establish the safety and tolerability of BSG005 in patients with severe invasive fungal infection
Renal function (eGFR)
To assess the overall response to BSG005 treatment in patients with invasive fungal infection
Overall response as per guidelines (composite of clinical, radiology, microbiology) Treatment success - complete \& partial response, \& stabile disease Treatment failure - progression Dose estimation for treatment success based on fungal infection strain Mortality during the course of the study (crude \& associated)
To assess the overall response to BSG005 treatment in patients with invasive fungal
To guide dose selection for future testing
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Biosergen AS
Lead sponsor
Alkem Laboratories Ltd
Collaborator
JSS Medical Research Asia pacific Private Limited
Collaborator
