Invasive Fungal InfectionPhase 1/2NCT06678113
Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection
A Phase 1/2 study testing BSG005 in people with Invasive Fungal Infection, run by Biosergen AS at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Invasive Fungal Infection
- What is being tested?
- BSG005
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2024to 1 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Proven IFIs as defined in the 2020 consensus definitions by the European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research Consortium (EORTC/MSGERC). Probable or possible IFIs can be included using the EORTC/MSGERC criteria or other established criteria. The inclusion of patients with IFI caused by, eg, Aspergillus spp and Candida spp, is preferred as these species are generally known to be responsive to a lower dose than other species, eg, Mucor mycosis
- 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
- Failure with one first-line agent, defined as either: Radiologic progression, Increase in serologic markers such as galactomannan antigen or beta-D-glucan, Failure of clearance of cultures , Progression or lack of improvement in a clinically appropriate timeframe of clinical symptoms attributed to IFI;
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- Inability to tolerate AmB, as defined by at least one of the following: Nephrotoxicity with either: 1.5 mg/dL increase in creatinine from baseline, 50% increase in creatinine from baseline ii. Contraindication to use AmB with either:- Persistent hypokalemia or hypomagnesemia while on AmB despite appropriate electrolyte replacement
- Documented in vitro resistance to first-line antifungal therapy (ie fluconazole resistance in Candida auris)
- Treatment-limiting drug-drug interactions prohibiting the use of antifungals (azoles and echinocandins) such as concurrent rifampcin, rifabutin, phenytoin, carbamazepine, bedaqualine
Who cannot join
- 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.
- Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.
- Has liver enzyme results (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) greater than 5 times the upper limit of normal.
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- Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.
- Has a bilirubin level greater than 5 times the upper limit of normal. Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.
- Patients who have an ejection fraction less than 25% of predicted.
- Currently pregnant or planning on getting pregnant while on study (details of contraception guidance are provided in Section 13).
- Breastfeeding.
- Patients not likely to survive a minimum of 28 days from start of screening.
- Patient receiving prohibited medications.
- Patient is an abuser of alcohol or medication.
- -
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
JSS Medical Research Asia Pacific Private Limited
Dehli, Haryana, 121003
Neeraj Prasad, Dr, +919930740633, neeraj.prasad@jssresearch.com
Pawan Kumar Singh, Dr
About this study
Official title: A Phase 1b, Single Arm, Multi-center, Open-label, Dose-escalation Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection
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.
Read the detailed description
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.
- Conditions
- Invasive Fungal Infection
- Being tested
- BSG005
- Keywords
- Invasive fungal infection, BSG005, Polyene macrolide, Rescue therapy
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSG005Drug
Also called Polyene Macrolide
Single arm dose escalation in patients with invasive fungal infection
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | The patient will receive active treatment in a dose escalation manner increasing the dose every 3 days dependent on safety and efficacy Receives: Drug: BSG005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the safety and tolerability of BSG005 in patients with severe invasive fungal infection
Treatment Emergent Adverse Event (CTC grading of severity)
Measured: 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)
Measured: From enrollment to end of treamtent including 14 days follow up
Secondary outcomes (2)
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)
Measured: 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
Measured: From treatment start to end of treatment plus 14 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Jul 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosergen AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alkem Laboratories Ltd, JSS Medical Research Asia pacific Private Limited
- Responsible party
- Sponsor
- Investigators
- Tine Olesen, PhD, Study chair, BIOSERGEN AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678113
- Sponsor's protocol ID
- BSG-1.02
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Safety and efficacy data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Single Arm, Multi-center, Open-label, Dose-escalation Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection
- ClinicalTrials.gov ID
- NCT06678113
- Acronym / sponsor ID
- BSG-1.02
- Conditions
- Invasive Fungal Infection
- Keywords
- Invasive fungal infection, BSG005, Polyene macrolide, Rescue therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Biosergen ASIndustry (pharma, biotech, devices)
- Collaborators
- Alkem Laboratories Ltd, JSS Medical Research Asia pacific Private Limited
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Drug: BSG005The patient will receive active treatment in a dose escalation manner increasing the dose every 3 days dependent on safety and efficacy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
- Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BSG005Also: Polyene MacrolideSingle arm dose escalation in patients with invasive fungal infection | Drug | Active treatment |
Primary outcome
To establish the safety and tolerability of BSG005 in patients with severe invasive fungal infection
Time frame: From enrollment to end of treamtent including 14 days follow up
Treatment Emergent Adverse Event (CTC grading of severity)
To establish the safety and tolerability of BSG005 in patients with severe invasive fungal infection
Time frame: From enrollment to end of treamtent including 14 days follow up
Renal function (eGFR)
2 secondary outcomes
To assess the overall response to BSG005 treatment in patients with invasive fungal infection
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
Time frame: From treatment start to end of treatment plus 14 days follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: Yes. Safety and efficacy data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tine Olesen, PhD study chair
BIOSERGEN AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BSG005 in people with Invasive Fungal Infection, run by Biosergen AS at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tine Olesen, CEO (+4531355707, tine.olesen@biosergen.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the safety and tolerability of BSG005 in patients with severe invasive fungal infection (time frame: From enrollment to end of treamtent including 14 days follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.