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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04921254




Registration number
NCT04921254
Ethics application status
Date submitted
24/04/2021
Date registered
10/06/2021
Date last updated
21/11/2022

Titles & IDs
Public title
A Study to Assess the Safety, Tolerability and Pharmacokinetics of BSG005.
Scientific 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
Secondary ID [1] 0 0
BSG1.01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Invasive Fungal Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BSG005 or placebo

Experimental: BSG005 - Active antifungal drug

Placebo Comparator: Placebo - Will be a 5% glucose infusion


Treatment: Drugs: BSG005 or 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AE recorded during and after BSG005 infusion
Timepoint [1] 0 0
On single dose(-1 to 7 days) and multiple dosing (- 1 to 14 days) changes.
Secondary outcome [1] 0 0
Pharmacokinetics of BSG005 infusion at different dose levels in SAD and MAD conditions
Timepoint [1] 0 0
24 hours.
Secondary outcome [2] 0 0
Cmax
Timepoint [2] 0 0
24 hours
Secondary outcome [3] 0 0
Tmax
Timepoint [3] 0 0
24 hours
Secondary outcome [4] 0 0
AUC (0-t)
Timepoint [4] 0 0
24 hours
Secondary outcome [5] 0 0
t1/2
Timepoint [5] 0 0
24 hours
Secondary outcome [6] 0 0
Steady state concentration
Timepoint [6] 0 0
8 days

Eligibility
Key inclusion criteria
To be included in this study, each individual must satisfy all the following criteria:

1. Male adult subjects aged 18 - 55 years at screening.

2. Subjects without concurrent illnesses who do not require any medical treatments.

3. 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.

4. Body Mass Index =18 and <30 kg/m2 and a weight of at least 50 kg.

5. Negative drug and alcohol screen in urine. Negative pregnancy test (females)

6. Subject is a non-smoker or smokes = 10 cigarettes per day (or equivalent).

7. Must be able and willing to provide written informed consent.

8. 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.

9. If sexually active males, must use a condom OR abstinence OR same sex partner OR
surgically sterile OR partner is of non-childbearing potential.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
If an individual meets any of the following criteria, he or she is ineligible for this
study:

1. 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.

2. Any clinical evidence that the Investigator feels would place the subject at increased
risk with the investigational product.

3. 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.

4. 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.

5. 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

6. Subject with, or history of clinically significant neurologic, gastrointestinal,
renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine,
hematological, or other major disorders.

7. 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.

8. 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.

9. 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.

10. 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.

11. Subject who has had a clinically significant illness within four weeks prior to
screening in the opinion of the Investigator.

12. 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.

13. 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).

14. 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).

15. 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.).

16. Subject who has consumed any grapefruit containing product on the day of clinic
check-in.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2023
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biosergen AS
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Select Pharma Pty Ltd
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Greenlight Clinical
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Nucleus Network Ltd
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04921254
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philippe Ryan, MD
Address 0 0
Nucleus Network, Melbourne site, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Peder M Andersen, MD
Address 0 0
Country 0 0
Phone 0 0
+45 20802470
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04921254