Actively Recruiting
Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection
Led by Biosergen AS · Updated on 2025-04-06
15
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
B
Biosergen AS
Lead Sponsor
A
Alkem Laboratories Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to provide written informed consent or have a legally authorized representative to consent if incapacitated
- Diagnosed with an invasive fungal infection by the investigator
- Proven, probable, or possible invasive fungal infection using established criteria, preferably caused by Aspergillus spp or Candida spp
- Patients with mild to moderate kidney impairment or needing alternative treatment due to failure or intolerance of first-line antifungal agents
- Patients who have failed treatment due to radiologic progression, increased serologic markers, culture clearance failure, or worsening clinical symptoms
- Patients intolerant to amphotericin B due to nephrotoxicity or electrolyte imbalances despite replacement
- Patients with documented resistance to first-line antifungal therapy
- Patients with drug interactions limiting antifungal use
You will not qualify if you...
- Known allergy or severe infusion reaction to polyene drugs
- Infection caused by organisms resistant to amphotericin B
- Use of another investigational drug within 30 days prior to enrollment
- Chronic kidney disease with eGFR less than 30 mL/min or dialysis; acute kidney injury patients with improving kidney function may be included
- Liver enzyme levels (AST or ALT) greater than 5 times the upper limit of normal
- Bilirubin levels greater than 5 times the upper limit of normal
- Ejection fraction less than 25% of predicted
- Pregnant or planning pregnancy during the study
- Breastfeeding
- Expected survival less than 28 days from screening start
- Use of prohibited medications
- Alcohol or drug abuse
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
JSS Medical Research Asia Pacific Private Limited
Dehli, Haryana, India, 121003
Actively Recruiting
Research Team
T
Tine Olesen, CEO
CONTACT
N
Niels Laursen, CFO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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