Infectious DiseasesPhase 1NCT05088421
A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of BWC0977 in Healthy Volunteers
A Phase 1 study testing BWC0977 in people with Infectious Diseases and Bacterial Infections, run by Bugworks Research Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Diseases, Bacterial Infections
- What is being tested?
- BWC0977
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Nov 2021to 28 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Each subject must meet all of the following criteria to be eligible for study participation:
- Healthy male or female 18 to 55 years of age, inclusive, at time of consent.
- Body mass index (BMI) ≥ 19.0 and ≤ 30.0 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
- Medically healthy without clinically significant abnormalities at the screening visit or Day -1, including:
- 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.
- 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.
- Clinically significant abnormalities in the screening clinical laboratory tests, as determined by the Investigator. Repeat testing could be performed at the Investigator's discretion.
- Willing
Who cannot join
- Volunteers who meet any of the following criteria will be excluded from the study:
- Women who are pregnant and/or nursing.
- 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.
- 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.
- History of photosensitivity to quinolones.
- History of known or suspected Clostridium difficile infection.
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- Any condition that necessitated hospitalisation within the 3 months prior to Day -1 or is likely to require so during the study.
- 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.
- 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.
- Documented hypersensitivity reaction or anaphylaxis to any medication.
- Smoker (including tobacco, e-cigarettes or marijuana) or nicotine user within 1 month prior to participation in the study
- 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).
- 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.
- 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.
- 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.
- Employee or family member of an employee of the Sponsor, CRU, or clinical research organization at which the study will be conducted.
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
This Phase 1 study is designed to assess the safety, tolerabilty and pharmcokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers. This is a randomized double-blind, placebo-controlled, ascending dose, multi-cohort trial. A total of 64 healthy volunteers are expected to be enrolled into 8 Cohorts. The study will be conducted in two phases: A single ascending dose (SAD) phase, followed by a multiple ascending dose (MAD) phase. In SAD, participants in Cohorts 1 - 5 will receive one dose of BWC0977 or placebo. In MAD, participants in Cohorts 6 - 8 will receive multiple doses of BWC0977 or placebo for 10 consecutive days at a dose deemed safe and tolerable as determined in the preceding SAD Cohorts. In both parts sequential cohorts will be exposed to increasing doses of BWC0977.
- Conditions
- Infectious Diseases, Bacterial Infections
- Being tested
- BWC0977, Placebo
- Keywords
- Safety, Tolerability, Pharmacokinetics, BWC0977
- Medical subject headings
- Communicable Diseases, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BWC0977Drug
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.
PlaceboDrug
Also called Compounded solution minus BWC0977
SAD Cohorts: Two participants in each cohort will receive matching placebo. MAD Cohorts: Two participants in each cohort will receive matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| BWC0977 | Experimental | 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. Receives: Drug: BWC0977 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs and serious adverse events (SAEs) overall and by intensity (Safety and tolerability).
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.
Measured: SAD: Up to 7 days; MAD: Up to 15 days.
Secondary outcomes (13)
AUC[0-t] of BWC0977 following single dose administration
Area under the plasma concentration curve from time zero to last time of quantifiable concentration (AUC[0-t]) of BWC0977 following single dose administration
Measured: 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
AUC[0-inf]) of BWC0977 following single dose administration
AUC from time zero to infinity (AUC[0-inf]) of BWC0977 following single dose administration
Measured: 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
AUC[0-8], AUC[0-12], AUC[0-24]) of BWC0977 following single dose administration
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
Measured: 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
Cmax of BWC0977 following single dose administration
Maximum observed plasma concentration (Cmax) of BWC0977 following single dose administration
Measured: 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
Cmax of BWC0977 following repeat dose administration
Maximum observed plasma concentration (Cmax) of BWC0977 following repeat dose administration
Measured: 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
Terminal half-life (T1/2)
Terminal half-life (T1/2) of BWC0977 following single dose administration
Measured: 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
Systemic clearance (CL) following single dose administration
Systemic clearance (CL) of BWC0977 following single dose administration
Measured: 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
Systemic clearance (CL) following repeat dose administration
Systemic clearance (CL) of BWC0977 following repeat dose administration
Measured: 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
Volume of distribution at steady state (Vdss) following single dose administration
Volume of distribution at steady state (Vdss) of BWC0977 following single dose
Measured: 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
Mean residence time (MRT) following single dose administration
Mean residence time (MRT) of BWC0977 following single dose administration
Measured: 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
Pre-dose (trough) concentration (Cτ) at the end of the dosing interval
Pre-dose (trough) concentration (Cτ) at the end of the dosing interval of BWC0977 following repeat dose administration
Measured: 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
Observed accumulation ratio following repeat dose administration
Observed accumulation ratio (Ro) of BWC0977 following repeat dose administration
Measured: 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
Volume of distribution at steady state following repeat dose administration
Volume of distribution at steady state (Vdss) of BWC0977 following repeat dose
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start5 Nov 2021
- Primary completion29 Dec 2022
- Study completion28 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infectious DiseasesStudies 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
- Randomized, double-blind, placebo-controlled, combined single and multiple ascending dose (SAD and MAD) trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bugworks Research Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Angela Molga, MD, Principal investigator, CMAX Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088421
- Sponsor's protocol ID
- C001-2020-01
- Status last verified
- Jul 2023
- First submitted
- 9 Sep 2021
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hameed P S, Kotakonda H, Sharma S, Nandishaiah R, Katagihallimath N, Rao R, Sadler C, Slater I, Morton M, Chandrasekaran A, Griffen E, Pillai D, Reddy S, Bharatham N, Venkatesan S, Jonnalagadda V, Jayaraman R, Nanjundappa M, Sharma M, Raveendran S, Rajagopal S, Tumma H, Watters A, Becker H, Lindley J, Flamm R, Huband M, Sahm D, Hackel M, Mathur T, Kolamunnage-Dona R, Unsworth J, Mcentee L, Farrington N, Manickam D, Chandrashekara N, Jayachandiran S, Reddy H, Shanker S, Richard V, Thomas T, Nagaraj S, Datta S, Sambandamurthy V, Ramachandran V, Clay R, Tomayko J, Das S, V B. BWC0977, a broad-spectrum antibacterial clinical candidate to treat multidrug resistant infections. Nat Commun. 2024 Sep 18;15(1):8202. doi: 10.1038/s41467-024-52557-2.
PubMed 39294149
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05088421
- Acronym / sponsor ID
- C001-2020-01
- Conditions
- Infectious Diseases, Bacterial Infections
- Keywords
- Safety, Tolerability, Pharmacokinetics, BWC0977
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bugworks Research Inc.Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 28 May 2023 (actual)
- First posted
- 21 Oct 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.
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.
Detailed description
This Phase 1 study is designed to assess the safety, tolerabilty and pharmcokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers. This is a randomized double-blind, placebo-controlled, ascending dose, multi-cohort trial. A total of 64 healthy volunteers are expected to be enrolled into 8 Cohorts. The study will be conducted in two phases: A single ascending dose (SAD) phase, followed by a multiple ascending dose (MAD) phase. In SAD, participants in Cohorts 1 - 5 will receive one dose of BWC0977 or placebo. In MAD, participants in Cohorts 6 - 8 will receive multiple doses of BWC0977 or placebo for 10 consecutive days at a dose deemed safe and tolerable as determined in the preceding SAD Cohorts. In both parts sequential cohorts will be exposed to increasing doses of BWC0977.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, combined single and multiple ascending dose (SAD and MAD) trial
| Arm | Type | Receives |
|---|---|---|
| BWC0977 | Experimental | Drug: BWC0977SAD 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 | Placebo comparator | Drug: PlaceboCompounded 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Each subject must meet all of the following criteria to be eligible for study participation:
- Healthy male or female 18 to 55 years of age, inclusive, at time of consent.
- Body mass index (BMI) ≥ 19.0 and ≤ 30.0 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
- Medically healthy without clinically significant abnormalities at the screening visit or Day -1, including:
- Willing
Key exclusion criteria (20 listed)
- Women who are pregnant and/or nursing.
- 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.
- 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.
- History of photosensitivity to quinolones.
- History of known or suspected Clostridium difficile infection.
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 |
|---|---|---|
| BWC0977SAD 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. | Drug | BWC0977 |
| PlaceboAlso: Compounded solution minus BWC0977SAD Cohorts: Two participants in each cohort will receive matching placebo. MAD Cohorts: Two participants in each cohort will receive matching placebo. | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs and serious adverse events (SAEs) overall and by intensity (Safety and tolerability).
Time frame: SAD: Up to 7 days; MAD: Up to 15 days.
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.
13 secondary outcomes
AUC[0-t] of BWC0977 following single dose administration
Time frame: 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
AUC[0-inf]) of BWC0977 following single dose administration
Time frame: 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
AUC[0-8], AUC[0-12], AUC[0-24]) of BWC0977 following single dose administration
Time frame: 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
Cmax of BWC0977 following single dose administration
Time frame: 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
Cmax of BWC0977 following repeat dose administration
Time frame: 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
Terminal half-life (T1/2)
Time frame: 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
Systemic clearance (CL) following single dose administration
Time frame: 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
Systemic clearance (CL) following repeat dose administration
Time frame: 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
Volume of distribution at steady state (Vdss) following single dose administration
Time frame: 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
Mean residence time (MRT) following single dose administration
Time frame: 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
Pre-dose (trough) concentration (Cτ) at the end of the dosing interval
Time frame: 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
Observed accumulation ratio following repeat dose administration
Time frame: 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
Volume of distribution at steady state following repeat dose administration
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 39294149Hameed P S, Kotakonda H, Sharma S, Nandishaiah R, Katagihallimath N, Rao R, Sadler C, Slater I, Morton M, Chandrasekaran A, Griffen E, Pillai D, Reddy S, Bharatham N, Venkatesan S, Jonnalagadda V, Jayaraman R, Nanjundappa M, Sharma M, Raveendran S, Rajagopal S, Tumma H, Watters A, Becker H, Lindley J, Flamm R, Huband M, Sahm D, Hackel M, Mathur T, Kolamunnage-Dona R, Unsworth J, Mcentee L, Farrington N, Manickam D, Chandrashekara N, Jayachandiran S, Reddy H, Shanker S, Richard V, Thomas T, Nagaraj S, Datta S, Sambandamurthy V, Ramachandran V, Clay R, Tomayko J, Das S, V B. BWC0977, a broad-spectrum antibacterial clinical candidate to treat multidrug resistant infections. Nat Commun. 2024 Sep 18;15(1):8202. doi: 10.1038/s41467-024-52557-2.
- 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.
Angela Molga, MD principal investigator
CMAX Clinical Research
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 testing BWC0977 in people with Infectious Diseases and Bacterial Infections, run by Bugworks Research Inc. 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 8 inclusion and 20 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: finished, as of the sponsor's last update on 6 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs and serious adverse events (SAEs) overall and by intensity (Safety and tolerability). (time frame: SAD: Up to 7 days; MAD: Up to 15 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05088421, which also lists 1 linked publication.
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 Jul 2023.