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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05088421
Registration number
NCT05088421
Ethics application status
Date submitted
9/09/2021
Date registered
21/10/2021
Titles & IDs
Public title
A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of BWC0977 in Healthy Volunteers
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of BWC0977 in Healthy Adult Volunteers
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Secondary ID [1]
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C001-2020-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infectious Diseases
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Bacterial Infections
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BWC0977
Treatment: Drugs - Placebo
Experimental: BWC0977 - SAD Cohorts: Subjects will receive single doses of BWC0977 via IV infusion over 2 hours. Planned doses to be studied are 120, 240, 480, 720, and 1050mg.
MAD Cohorts: Subjects will receive multiple doses of 240mg TID 7 days, 350mg TID 7 days BWC0977 via IV infusion over 2 hours in the first 2 cohorts. The dose for the B3 cohort will be determined based on safety and tolerability data from the previous two cohorts Up to three dose groups will be studied.
Placebo comparator: Placebo - Compounded solution minus BWC0977 The placebo used during this study is 5% Dextrose for injection. SAD Cohorts: Subjects will receive single infusions of placebo (Compounded solution minus BWC0977) over two hour.
MAD Cohorts: Subjects will receive multiple infusions of placebo over 2 hour for 10 consecutive days. Frequency of infusions will be determined based on safety, tolerability and PK data obtained for BWC0977 in SAD Cohorts.
Treatment: Drugs: BWC0977
SAD Cohorts: Double-blind dosing will occur. Six participants will receive single doses of BWC0977. The dose escalation steps may be altered following review of the safety data upon completion of each cohort.
MAD Cohorts: Double blind dosing will occur. Six participants in each cohort will receive multiple doses of BWC0977. The dose escalation steps may be altered following review of the safety data upon completion of each cohort. Dosing will commence on the morning of Day 1. Dosing frequency to be confirmed based on safety, tolerability and PK data from SAD cohorts. Daily dosing will continue for a total of 10 consecutive days.
Treatment: Drugs: Placebo
SAD Cohorts: Two participants in each cohort will receive matching placebo. MAD Cohorts: Two participants in each cohort will receive matching placebo.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of treatment-emergent adverse events (TEAEs and serious adverse events (SAEs) overall and by intensity (Safety and tolerability).
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Assessment method [1]
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This outcome combines the measure of the number of participants experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatment.
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Timepoint [1]
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SAD: Up to 7 days; MAD: Up to 15 days.
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Secondary outcome [1]
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AUC[0-t] of BWC0977 following single dose administration
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Assessment method [1]
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Area under the plasma concentration curve from time zero to last time of quantifiable concentration (AUC\[0-t\]) of BWC0977 following single dose administration
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Timepoint [1]
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Day 1 pre-dose, 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours post infusion start
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Secondary outcome [2]
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AUC[0-inf]) of BWC0977 following single dose administration
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Assessment method [2]
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AUC from time zero to infinity (AUC\[0-inf\]) of BWC0977 following single dose administration
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Timepoint [2]
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Day 1 pre-dose, 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours post infusion start
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Secondary outcome [3]
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AUC[0-8], AUC[0-12], AUC[0-24]) of BWC0977 following single dose administration
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Assessment method [3]
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AUC from time zero to 8, 12, and 24 hours (AUC\[0-8\], AUC\[0-12\], AUC\[0-24\]) of BWC0977 following single dose administration
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Timepoint [3]
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Day 1 pre-dose, 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours post infusion start
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Secondary outcome [4]
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Cmax of BWC0977 following single dose administration
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Assessment method [4]
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Maximum observed plasma concentration (Cmax) of BWC0977 following single dose administration
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Timepoint [4]
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Day 1 pre-dose, 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours post infusion start
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Secondary outcome [5]
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Cmax of BWC0977 following repeat dose administration
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Assessment method [5]
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Maximum observed plasma concentration (Cmax) of BWC0977 following repeat dose administration
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Timepoint [5]
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Day 1 pre-dose, 30, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, and 8 hours post infusion start Days 5, 6, 7, 8, and 9: pre-dose Day 10 pre-dose, 30, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours post infusion start
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Secondary outcome [6]
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Terminal half-life (T1/2)
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Assessment method [6]
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Terminal half-life (T1/2) of BWC0977 following single dose administration
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Timepoint [6]
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Day 1 pre-dose, 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours post infusion start
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Secondary outcome [7]
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Systemic clearance (CL) following single dose administration
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Assessment method [7]
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Systemic clearance (CL) of BWC0977 following single dose administration
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Timepoint [7]
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Day 1 pre-dose, 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours post infusion start
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Secondary outcome [8]
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Systemic clearance (CL) following repeat dose administration
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Assessment method [8]
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Systemic clearance (CL) of BWC0977 following repeat dose administration
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Timepoint [8]
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Day 1 pre-dose, 30, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, and 8 hours post infusion start Days 5, 6, 7, 8, and 9: pre-dose Day 10 pre-dose, 30, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours post infusion start
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Secondary outcome [9]
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Volume of distribution at steady state (Vdss) following single dose administration
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Assessment method [9]
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Volume of distribution at steady state (Vdss) of BWC0977 following single dose
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Timepoint [9]
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Day 1 pre-dose, 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours post infusion start
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Secondary outcome [10]
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Mean residence time (MRT) following single dose administration
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Assessment method [10]
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Mean residence time (MRT) of BWC0977 following single dose administration
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Timepoint [10]
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Day 1 pre-dose, 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours post infusion start
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Secondary outcome [11]
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Pre-dose (trough) concentration (Ct) at the end of the dosing interval
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Assessment method [11]
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Pre-dose (trough) concentration (Ct) at the end of the dosing interval of BWC0977 following repeat dose administration
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Timepoint [11]
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Day 1 pre-dose, 30, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, and 8 hours post infusion start Days 5, 6, 7, 8, and 9: pre-dose Day 10 pre-dose, 30, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours post infusion start
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Secondary outcome [12]
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Observed accumulation ratio following repeat dose administration
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Assessment method [12]
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Observed accumulation ratio (Ro) of BWC0977 following repeat dose administration
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Timepoint [12]
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Day 1 pre-dose, 30, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, and 8 hours post infusion start Days 5, 6, 7, 8, and 9: pre-dose Day 10 pre-dose, 30, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours post infusion start
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Secondary outcome [13]
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Volume of distribution at steady state following repeat dose administration
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Assessment method [13]
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Volume of distribution at steady state (Vdss) of BWC0977 following repeat dose
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Timepoint [13]
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Day 1 pre-dose, 30, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, and 8 hours post infusion start Days 5, 6, 7, 8, and 9: pre-dose Day 10 pre-dose, 30, 60, 75, and 90 minutes and 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours post infusion start
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Eligibility
Key inclusion criteria
Each subject must meet all of the following criteria to be eligible for study participation:
1. Healthy male or female 18 to 55 years of age, inclusive, at time of consent.
2. Body mass index (BMI) = 19.0 and = 30.0 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
3. Medically healthy without clinically significant abnormalities at the screening visit or Day -1, including:
1. No findings in Physical examination or vital signs (including temperature, heart rate, respiratory rate, and blood pressure) that the Principal Investigator (PI) determines would interfere with interpretation of study results.
2. Electrocardiograms (ECGs) without clinically significant abnormalities, including a QT duration corrected for heart rate by Fridericia's formula (QTcF) interval duration =450 msec (for males), and =470 msec (for females) obtained as an average from the triplicate screening ECGs after at least 5 minutes in a supine quiet-rest position.
3. Clinically significant abnormalities in the screening clinical laboratory tests, as determined by the Investigator. Repeat testing could be performed at the Investigator's discretion.
4. Willing
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Volunteers who meet any of the following criteria will be excluded from the study:
1. Women who are pregnant and/or nursing.
2. History or presence of significant cardiovascular (including QT prolongation, clinically significant hypokalemia, or other proarrhythmic conditions), pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine (including glucose intolerance, diabetes mellitus), immunologic (including asthma or seasonal allergies [that require intermittent use of steroids or other medication]), musculoskeletal (including tendinopathy), dermatologic, or neurological disease (including seizure disorders, psychiatric disorders), including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant.
3. A serum creatinine value on Day -1 (check-in) that increased by more than 0.2 mg/dL (or 15.25 µmol/L) from the Screening value.
4. History of photosensitivity to quinolones.
5. History of known or suspected Clostridium difficile infection.
6. Any condition that necessitated hospitalisation within the 3 months prior to Day -1 or is likely to require so during the study.
7. Positive test for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV antibodies), or human immunodeficiency virus antibody (antibodies to HIV-1, HIV-2) or tuberculosis (TB) at screening.
8. Exposure to any prescription medications (small molecules, biologics including vaccines) or, systemically administered OTC drugs, dietary supplements or herbal remedies, within 30 days or 5 half-lives (if known), whichever is longer, prior to Day -1. Discussion between the PI and the Sponsor Medical Monitor is encouraged regarding prior use of any medications during the pre-dose period.
Note: An exception is made for hormonal contraceptives and a limited amount of paracetamol (a maximum of 4 doses per day of 500-mg paracetamol, and no more than 3 g per week) for the treatment of headache or any other pain.
9. Documented hypersensitivity reaction or anaphylaxis to any medication.
10. Smoker (including tobacco, e-cigarettes or marijuana) or nicotine user within 1 month prior to participation in the study
11. Positive urine drug/alcohol testing at screening or check-in (Day -1), or history of substance abuse or alcohol abuse (defined as greater than 2 standard drinks on average each and every day, where one standard drink is defined as containing 10 g of alcohol and is equivalent to 1 can or stubby of mid-strength beer, 30 ml nip spirits, or 100 ml wine) within the previous 5 years (may be repeated once per timepoint, at the discretion of the PI, in the instance of a positive result).
12. Donation of blood or plasma within 30 days prior to randomization, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of study enrollment.
13. Previous participation in this study or previous participation in another study within 5 half-lives (if known) of the agent, whichever is longer, of Day 1. Note: prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable.
14. Consumption of red wine, seville oranges, grapefruit or grapefruit juice, pummelos, other citrus fruits, grapefruit hybrids or fruit juices containing such products from 7 days prior to the first dose of study medication.
15. Employee or family member of an employee of the Sponsor, CRU, or clinical research organization at which the study will be conducted.
16. Unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non-compliant with any study requirements.
17. Any disease or condition (medical or surgical) that, by the determination of the PI, precludes the subject's participation in the study or would place the subject at risk as a result of participation in the study.
Note: Volunteers should refrain from consumption of any foods containing poppy seeds within 48 hours (2 days) prior to screening and prior to Day -1 to avoid false positive drug screen results
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/11/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/05/2023
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Sample size
Target
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Accrual to date
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Final
44
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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CMAX Clinical Research - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bugworks Research Inc.
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Avance Clinical Pty Ltd.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers.
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Trial website
https://clinicaltrials.gov/study/NCT05088421
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Angela Molga, MD
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Address
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CMAX Clinical Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05088421