Invasive Fungal InfectionsPhase 1NCT04921254
A Study to Assess the Safety, Tolerability and Pharmacokinetics of BSG005.
A Phase 1 study of Invasive Fungal Infections, run by Biosergen AS at 1 site in Australia.
Trial summary
A Phase 1, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of BSG005 following single and multiple ascending doses in healthy subjects. The study will include a single ascending dose part and a multiple ascending dose part Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Invasive Fungal Infections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 23 Aug 2021to May 2023
- Phase
- Phase 1
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be included in this study, each individual must satisfy all the following criteria:
- Male adult subjects aged 18 - 55 years at screening.
- Subjects without concurrent illnesses who do not require any medical treatments.
- Judged by an Investigator to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), 12-lead ECG, vital sign assessments, clinical laboratory assessments, and by general observations. Any abnormalities or deviations outside the normal ranges for any of clinical testing (laboratory tests, ECG, vital signs) can be repeated at the discretion of the Investigator(s) and/or judged to be not clinically significant for study participation.
- Body Mass Index ≥18 and <30 kg/m2 and a weight of at least 50 kg.
- Negative drug and alcohol screen in urine. Negative pregnancy test (females)
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- Subject is a non-smoker or smokes ≤ 10 cigarettes per day (or equivalent).
- Must be able and willing to provide written informed consent.
- Are willing to remain in the study unit for the entire duration of the treatment period, attend all scheduled visits, and comply with all study procedures.
- If sexually active males, must use a condom OR abstinence OR same sex partner OR surgically sterile OR partner is of non-childbearing potential.
Who cannot join
- If an individual meets any of the following criteria, he or she is ineligible for this study:
- Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device.
- Any clinical evidence that the Investigator feels would place the subject at increased risk with the investigational product.
- Subject shows clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, or clinical laboratory parameters for the screening assessments (especially for liver enzymes, and serum creatinine and estimated creatinine clearance) according to the Investigator's judgment.
- Has liver enzyme results (AST, ALT, GGT) above the upper normal limit (UNL): AST 37 U/L; ALT 78 U/L; GGT 55 U/L.
- Has a creatinine value outside the normal range (female <0.51 mg/dL; male <0.67 mg/dL) and an estimated creatinine clearance (Cockcroft-Gault) < 30 mL/min
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- Subject with, or history of clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
- Subject who has a sitting or lying blood pressure at screening, after resting for at least 5 minutes: systolic blood pressure > 155 or < 90 mmHg, or diastolic blood pressure > 90 or < 40 mmHg.
- Subject who has a sitting or lying pulse rate at screening, after resting for at least 5 minutes, outside the range of < 39 or > 101 beats/min.
- Subject who donated blood or who had a comparable blood loss (approximately 500 mL) during the last 30 days prior to start of this study.
- Subject with a known history of clinically significant drug allergies in the opinion of the Investigator or with a known allergy to any medicine chemically related to the study medication.
- Subject who has had a clinically significant illness within four weeks prior to screening in the opinion of the Investigator.
- Subject with a history of chronic alcohol (regular daily intake of more than, e.g., three standard drinks) or drug abuse within the last 6 months prior to first administration or evidence of such abuse as indicated by the laboratory profile conducted during the screening examination.
- Subject who has received prescription drugs or OTC medication other than dietary supplements, occasional ibuprofen, standard dose vitamins, or herbal products within 2 weeks prior to the first administration (with the exception of up to 1000 mg acetaminophen per day).
- Subject who plans to take concomitant medications while enrolled in the study (with the exception of up to 1000 mg acetaminophen per day or vitamins, dietary supplements, or herbal products).
- Subject who received any treatment agents known to alter the major organs or systems within 30 days prior to the first administration (e.g., diuretics, nephro- or liver toxic medication, barbiturates, phenothiazines, cimetidine, more than 1.0 L of caffeine-containing beverages per day, etc.).
- Subject who has consumed any grapefruit containing product on the day of clinic check-in.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
Elaine Wong, +61 402 329 162, e.wong@nucleusnetwork.com.au
About this study
Official title: A Phase 1, Double-blinded, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of BSG005 Following Single and Multiple Ascending Doses in Healthy Subjects
A Phase 1, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of BSG005 following single and multiple ascending doses in healthy subjects. The study will include a single ascending dose part and a multiple ascending dose part
Read the detailed description
The study will investigate the safety and tolerability of BSG005 in healthy subjects. The study will also include pharmacokinetic investigations.
There will be an ascending single dose part (SAD) with 6 subject in a study dose cohort of which 2 will be placebo and 4 will be on active drug. This concept will be replicated in the multiple ascending dose (MAD) part.
There is expected to be up to6 cohorts in SAD part with a starting dose calculated from the GLP NOAEL dose levels and from that increasing dose levels will be tested after a Safety Review Committee (SRC) has approved the escalation to next dose level. The key parameters are infusion reactions, kidney, liver and potassium changes during and after administration of BSG005.
Depending on the outcome of the SAD part the MAD part may include 4 or 5 dose levels administered daily over 7 days. Key parameters are the same as in the SAD part but extended to cover monitoring over 14 days. Pharmacokinetics at day 1 and day 7 will be investigated.
Key evaluation is on safety and tolerability during and after 7 days of dosing and pharmacokinetic investigations and the steady state plasma levels.
- Conditions
- Invasive Fungal Infections
- Being tested
- BSG005 or placebo
- 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.
BSG005 or placeboDrug
Also called BSG005, Placebo
SAD part is a single IV infusion of ascending doses of BSG005 or placebo - a 30 minutes infusion that may be extended to 2 hours if infusion reactions occur.
The MAD part is single daily infusions of the cohort dose over 30 minutes (that may be delayed up to 2 hours in case of infusion reactions) and which will be repeated daily for 7 days. Objective is safety, tolerability and PK on day 1 and day 7 and to establish steady state plasma level.
| Study group | Role | What they receive |
|---|---|---|
| BSG005 | Experimental | Active antifungal drug Receives: Drug: BSG005 or placebo |
| Placebo | Placebo comparator | Will be a 5% glucose infusion Receives: Drug: BSG005 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE recorded during and after BSG005 infusion
The Investigator will carefully monitor each subject throughout the study for any AEs (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities [MedDRA])
Measured: On single dose(-1 to 7 days) and multiple dosing (- 1 to 14 days) changes.
Secondary outcomes (6)
Pharmacokinetics of BSG005 infusion at different dose levels in SAD and MAD conditions
Area under the concentration-time curve from time 0 (predose) to time 24 hours.
Measured: 24 hours.
Cmax
Maximum concentration (Cmax)
Measured: 24 hours
Tmax
Time to reach maximum concentration (Tmax)
Measured: 24 hours
AUC (0-t)
Area under concentration-time curve from time 0 (predose) to the last quantifiable data point (AUC(0-t))
Measured: 24 hours
t1/2
Terminal half-life (t1/2)
Measured: 24 hours
Steady state concentration
concentration on day 7 at pre-dose and at 24 hours on day 8 in MAS part
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start23 Aug 2021
- Primary completionMar 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single escalation dose safety, tolerability and PK followed by multiple escalation dose for safety, tolerability and PK.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosergen AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Select Pharma Pty Ltd, Greenlight Clinical, Nucleus Network Ltd
- Responsible party
- Sponsor
- Investigators
- Philippe Ryan, MD, Principal investigator, Nucleus Network, Melbourne site, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921254
- Sponsor's protocol ID
- BSG1.01
- Status last verified
- Nov 2022
- First submitted
- 24 Apr 2021
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blinded, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of BSG005 Following Single and Multiple Ascending Doses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04921254
- Acronym / sponsor ID
- BSG1.01
- Conditions
- Invasive Fungal Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Biosergen ASIndustry (pharma, biotech, devices)
- Collaborators
- Select Pharma Pty Ltd, Greenlight Clinical, Nucleus Network Ltd
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 10 Jun 2021 (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.
A Phase 1, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of BSG005 following single and multiple ascending doses in healthy subjects. The study will include a single ascending dose part and a multiple ascending dose part
Detailed description
The study will investigate the safety and tolerability of BSG005 in healthy subjects. The study will also include pharmacokinetic investigations.
There will be an ascending single dose part (SAD) with 6 subject in a study dose cohort of which 2 will be placebo and 4 will be on active drug. This concept will be replicated in the multiple ascending dose (MAD) part.
There is expected to be up to6 cohorts in SAD part with a starting dose calculated from the GLP NOAEL dose levels and from that increasing dose levels will be tested after a Safety Review Committee (SRC) has approved the escalation to next dose level. The key parameters are infusion reactions, kidney, liver and potassium changes during and after administration of BSG005.
Depending on the outcome of the SAD part the MAD part may include 4 or 5 dose levels administered daily over 7 days. Key parameters are the same as in the SAD part but extended to cover monitoring over 14 days. Pharmacokinetics at day 1 and day 7 will be investigated.
Key evaluation is on safety and tolerability during and after 7 days of dosing and pharmacokinetic investigations and the steady state plasma levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single escalation dose safety, tolerability and PK followed by multiple escalation dose for safety, tolerability and PK.
| Arm | Type | Receives |
|---|---|---|
| BSG005 | Experimental | Drug: BSG005 or placeboActive antifungal drug |
| Placebo | Placebo comparator | Drug: BSG005 or placeboWill be a 5% glucose infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male adult subjects aged 18 - 55 years at screening.
- Subjects without concurrent illnesses who do not require any medical treatments.
- Judged by an Investigator to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), 12-lead ECG, vital sign assessments, clinical laboratory assessments, and by general observations. Any abnormalities or deviations outside the normal ranges for any of clinical testing (laboratory tests, ECG, vital signs) can be repeated at the discretion of the Investigator(s) and/or judged to be not clinically significant for study participation.
- Body Mass Index ≥18 and <30 kg/m2 and a weight of at least 50 kg.
- Negative drug and alcohol screen in urine. Negative pregnancy test (females)
Key exclusion criteria (17 listed)
- If an individual meets any of the following criteria, he or she is ineligible for this study:
- Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device.
- Any clinical evidence that the Investigator feels would place the subject at increased risk with the investigational product.
- Subject shows clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, or clinical laboratory parameters for the screening assessments (especially for liver enzymes, and serum creatinine and estimated creatinine clearance) according to the Investigator's judgment.
- Has liver enzyme results (AST, ALT, GGT) above the upper normal limit (UNL): AST 37 U/L; ALT 78 U/L; GGT 55 U/L.
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 |
|---|---|---|
| BSG005 or placeboAlso: BSG005, PlaceboSAD part is a single IV infusion of ascending doses of BSG005 or placebo - a 30 minutes infusion that may be extended to 2 hours if infusion reactions occur. The MAD part is single daily infusions of the cohort dose over 30 minutes (that may be delayed up to 2 hours in case of infusion reactions) and which will be repeated daily for 7 days. Objective is safety, tolerability and PK on day 1 and day 7 and to establish steady state plasma level. | Drug | BSG005, Placebo |
Primary outcome
AE recorded during and after BSG005 infusion
Time frame: On single dose(-1 to 7 days) and multiple dosing (- 1 to 14 days) changes.
The Investigator will carefully monitor each subject throughout the study for any AEs (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities [MedDRA])
6 secondary outcomes
Pharmacokinetics of BSG005 infusion at different dose levels in SAD and MAD conditions
Time frame: 24 hours.
Cmax
Time frame: 24 hours
Tmax
Time frame: 24 hours
AUC (0-t)
Time frame: 24 hours
t1/2
Time frame: 24 hours
Steady state concentration
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Philippe Ryan, MD principal investigator
Nucleus Network, Melbourne site, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Invasive Fungal Infections, run by Biosergen AS at 1 site in Australia.
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 10 inclusion and 17 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 21 Nov 2022. 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 Australia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Peder M Andersen, MD (+45 20802470, peder.andersen@biosergen.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE recorded during and after BSG005 infusion (time frame: On single dose(-1 to 7 days) and multiple dosing (- 1 to 14 days) changes.). 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 21 Nov 2022.