A Phase 1/2 interventional study of BSG005 in Invasive Fungal Infection, sponsored by Biosergen AS. Recruiting at 1 site in India. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Biosergen AS · Phase 1/2, Interventional, and Treatment
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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 study is an open-label, Phase 1b, dose-escalation/finding study to assess safety and efficacy of intravenous BSG005 in patients with uncomplicated invasive fungal infections (IFI).
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. Following 7 days of Screening period, patients will be enrolled in the study. In Cohort 1, patients will be administered with a dose of 0.1 mg/kg, which was tested in the single ascending dose (SAD) group of the Phase 1 healthy subject study and will follow an intra-patient dose-escalation step. Based on the overall health status of the patient (safety and efficacy of study intervention), the dose can be adjusted at any point of time according to the Investigator´s judgment, which would be based on clinical or mycological or radiological assessments dependent on the information available. This can be dose escalation or dose de-escalation as appropriate. During the Treatment period, there may be a pause of one day or more if deemed necessary by the Investigator. Each patient will be evaluated individually for efficacy and safety to decide if escalation is possible. The dose will be escalated by 0.1 mg/kg every 3 days or 1 day earlier (ie, 2 days) at the Investigator's discretion.
The starting dose in Cohort 1 will be 0.1 mg/kg for the first 3 days of treatment; if no safety concerns are experienced, the patients will be escalated up to 0.2 mg/kg. This process will be followed up to a maximum of 1.0 mg/kg or till a maximum of 28 days of treatment duration in Cohort 1, with the possibility to stop anytime after 14 days depending on the status of the patient. The starting dose of Cohort 2 will be decided by the Data Safety Review Committee (DSRC) after review of all available relevant data up to Day 14 of treatment for all patients in Cohort 1. Subsequently, a similar dose-escalation will be followed for Cohort 2 as defined above for Cohort 1. The dose can be escalated up to a maximum of 2.0 kg/mg. A similar process will be followed for the first dose in Cohort 3 and the dose can be escalated up to a maximum of 3.0 mg/kg. BSG005 will be administered daily via IV infusion for 120 minutes (may be prolonged for up to 240 minutes). As BSG005 has a propensity for phlebitis, central catheters or long peripheral catheters are preferred for infusion.
136 studies on the registry are indexed under Invasive Fungal Infections; 33 are open to participants now.
This study's planned enrollment of 15 is below the median of 70 across 67 interventional studies indexed under Invasive Fungal Infections.
Browse Invasive Fungal Infections studies →Biosergen AS is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Chronic kidney disease with estimated (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.
Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.
Has liver enzyme results ( [AST]/alanine aminotransferase [ALT]) greater than 5 times the .
Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.
Patient is an abuser of alcohol or medication.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patient will receive active treatment in a dose escalation manner increasing the dose every 3 days dependent on safety and efficacy
Drug: BSG005
Single arm dose escalation in patients with invasive fungal infection
Also known as: Polyene Macrolide
To establish the safety and tolerability of BSG005 in patients with severe invasive fungal infection
Treatment Emergent Adverse Event (CTC grading of severity)
Time frame: From enrollment to end of treamtent including 14 days follow up
To establish the safety and tolerability of BSG005 in patients with severe invasive fungal infection
Renal function (eGFR)
Time frame: From enrollment to end of treamtent including 14 days follow up
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)
Time frame: From treatment start to end of treatment plus 14 days follow up
To assess the overall response to BSG005 treatment in patients with invasive fungal
To guide dose selection for future testing
Time frame: From treatment start to end of treatment plus 14 days follow up
Plan to share: Yes — Safety and efficacy data will be shared
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: The information will be available after end of study when the clinical trial report is written
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact tine.olesen@biosergen.net
Data sharing details ↗ · www.biosergen.net
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Dec 2025, 17 months after the start.
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