Infectious DiseasesPhase 1NCT07029932
A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers
A Phase 1 study testing BWC0977 in people with Infectious Diseases and Antimicrobial Drug Resistance, 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, Antimicrobial Drug Resistance
- 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
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Oct 2025to 30 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Age: Healthy male or female 18 to 55 years of age, inclusive, at time of consent
- Body mass index (BMI): BMI ≥ 19.0 and ≤ 30.0 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive)
- Health Status: Medically healthy without significant history of any chronic diseases or conditions (such as cardiovascular, renal, hepatic, neurological, hematological, gastrointestinal, endocrine, or musculoskeletal disorders). Volunteers must have no clinically significant abnormalities in medical history, as determined by the Investigator.
- Screening Tests:
- No findings in Physical examination or vital signs (including temperature, heart rate, respiratory rate, and blood pressure) that the Investigator determines would interfere with interpretation of study results
- Triplicate ECGs without clinically significant abnormalities, including a 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
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- For clinically significant abnormalities in the screening clinical laboratory tests, vital signs, and ECG assessments as determined by the Investigator, repeat testing could be performed at the Investigator's discretion
- Informed consent: Willing and able to provide written informed consent
- Compliance: Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of events.
- Physical Activity Restrictions: Willing to refrain from strenuous physical activity that could cause muscle aches or injury, including contact sports, at any time from 4 days prior to admission in the clinical research unit (CRU) until completion of the study.
- Venous Access: Have suitable venous access for drug administration and blood sampling
- Contraception Requirements (for those of reproductive potential): Contraception requirements will follow institutional policies.
- Females:
- Must agree to use two forms of effective contraception-male partner using a condom plus 1 other highly effective method of birth control (e.g., Hormonal methods of contraception including oral contraceptives {includes Combined estrogen-progestin oral contraceptives (COCs) and progestogen-only contraceptives associated with inhibition of ovulation}, a vaginal ring, injectable and implantable hormonal contraceptives, indwelling intrauterine device, history of bilateral tubal ligation, sole vasectomized (bilateral vasectomy) partner with documented azoospermia 90 days after procedure) from signing the consent form until 33 days after last study drug administration, or agree to complete sexual abstinence for the duration of the study from screening and for 33 days after last study drug administration. Females of child-bearing potential must also agree not to donate ova or oocytes (i.e., human eggs) during the study, and for 33 days after completion of the study. For female participants, hormonal contraceptives should begin at least 1 month prior to screening to ensure the contraceptive is in full effect.
- To be considered of non-childbearing potential, a female must have either a hysterectomy, bilateral salpingo-oophorectomy (at least 3 months prior to screening), or menopause {last menstruation >12 months in the absence of other biological causes and follicle-stimulating hormone levels in menopausal range (>40mIU/mL)}, provision of written documentation is not required for female sterilization and oral confirmation is adequate. Female participants in same sex relationships do not need to utilize contraception.
- Males:
- If sexually active with a female partner of childbearing potential, must agree to use male condom plus 1 other highly effective method of birth control in their partner (e.g., Hormonal methods of contraception including oral contraceptives {includes Combined estrogen-progestin oral contraceptives (COCs) and progestogen-only contraceptives associated with inhibition of ovulation}, a vaginal ring, injectable and implantable hormonal contraceptives, indwelling intrauterine device, history of bilateral tubal ligation) from signing the consent form until 93 days after last study drug administration, or agree to complete sexual abstinence for the duration of the study from screening and for 93 days after last study drug administration. Hormonal contraceptives should be in use by female partner for at least 1 month prior to screening to ensure contraceptive is in full effect.
- To be considered surgically sterile, male participants must have had bilateral vasectomy at least 3 months before screening with appropriate documentation of the absence of sperm in the ejaculate 90 days after procedure. The use of condom by male partner will be required if bilateral vasectomy is the chosen highly effective method of birth control.
- Male participants must also agree not to donate sperms during the study and for 93 days after the last dose of the study drug.
- Male participants in same sex relationships or sexually active with female of non-childbearing potential (as defined above) do not need to utilize contraception. Male participants with potentially postmenopausal partners who are under the age of 55 years must use condoms unless their partner's postmenopausal status has been confirmed by FSH level
Who cannot join
- 1) Pregnancy and Lactation: Women who are pregnant and/or lactating. 2) Significant Medical History: 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, as determined by the Investigator to be clinically relevant.
- History of any kidney disease or current or chronic history of impaired renal function as indicated by a calculated creatinine clearance (Cockcroft-Gault formula) <80 milliliter per minute (mL/min).
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert syndrome or asymptomatic gallstones) 3) Laboratory abnormalities
- Clinically significant abnormal findings in serum chemistry, hematology, coagulation or urinalysis results obtained at screening or check-in (Day-1) b) Alanine aminotransferase (ALT) more than (>)1 upper limit of normal (ULN) at screening or check-in (Day-1) c) Aspartate aminotransferase (AST) > ULN at screening or check-in (Day-1)d) Bilirubin >ULN at screening or check-in (Day-1) e) Serum creatinine > ULN at screening or check-in (Day-1). The serum creatinine or any laboratory test may be repeated prior to confirming exclusion, at the PI's discretion.
- 4) Electrocardiographic abnormalities: Baseline QTcF of >450 msec (for males), and >470 msec (for females) at screening or check-in (Day-1) 5) Photosensitivity: History of photosensitivity to quinolones 6) Clostridium Difficile: History of known or suspected Clostridium difficile infection 7) Hospitalization History: Any condition that necessitated hospitalization within the 3 months prior to Day -1 or is likely to require so during the study 8) Antibiotic History: No systemic antibiotic use within 5 days before dosing. 9) Infection History: 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) at screening.
- 10) Recent Medications: Exclude participants receiving all prescription and OTC medications (except hormonal contraception and Paracetamol) 14 days or 5 half-lives, whichever is longer, prior to IP dosing.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, paracetamol (a maximum of 4 doses per day of 500 mg, and no more than 3 g per week) for the treatment of headache or any other pain as per the PI's judgement.
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- 11) Hypersensitivity: DocumentedHistory of significant hypersensitivity reaction or anaphylaxis to any medication, as determined by the Medical Officer.
- 12) Tobacco and Nicotine Use: Smoker (including tobacco, e-cigarettes, or marijuana) or nicotine user within 1 month prior to dosing and have a positive test for cotinine at check in on Day -1 (may be repeated once, at the discretion of the Investigator or Medical officer, in the instance of a positive result).
- 13) Drug/Alcohol Abuse: Positive urine drug/alcohol breath 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 Investigator or Medical officer, in the instance of a positive result).
- 14) Blood/Plasma Donation: Donation of blood within 30 days or plasma within 7 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.
- 15) Previous Study Participation: Previous participation in this study, i.e., who has already completed earlier cohorts or previous participation in another study within 5 half-lives (if known) of the agent, or 30 days, 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. Those who were screen failures or not dosed in this study may will be considered for re-screening in subsequent cohorts.
- 16) Food Restrictions: Consumption of red wine, Seville oranges, grapefruit, or grapefruit juice, pummelos, exotic citrus fruits, grapefruit hybrids, or fruit juices containing such products from 7 days prior to the first dose of study medication.(Note: Lemon and lime, including their juice or zest, are permitted as they are not known to significantly affect cytochrome P450 (CYP3A4) enzyme activity) 17) Sponsor Relationships: Employee or family member of an employee of the Sponsor, CRU, or clinical research organization at which the study will be conducted.
- 18) Non-compliance: Unable to cooperate fully with the requirements of the study protocol, including the schedule of events, or likely to be non-compliant with any study requirements.
- 19) Other Medical Conditions: Any other disease or condition that, in the opinion of the Investigator, would preclude the subject's participation in the study or place them at risk as a result of study participation.
- 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. Examples of foods to avoid include: poppy seed bagels, muffins, pastries, salad dressings, or any baked goods or dishes that list poppy seeds as an ingredient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Balasubramanian V, PhD contact
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network
Melbourne, Victoria, 3004
+ 61 3 8593 9801
Aarthy Joseph, MBBS MD (General Medicine)
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, tolerability, and pharmacokinetics 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 in 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 - 2 will receive one dose of BWC0977 or placebo. In MAD, participants in cohorts 3 - 7 will receive multiple doses of BWC0977 or placebo for 7-10 consecutive days (as per the schedule). In both parts, sequential cohorts will be exposed to increasing doses of BWC0977.
- Conditions
- Infectious Diseases, Antimicrobial Drug Resistance
- Being tested
- BWC0977, Placebo
- Keywords
- safety, Tolerability, Pharmacokinetics, BWC0977
- Medical subject headings
- Communicable Diseases
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 and previous MAD cohorts. Daily dosing will continue for a total of 7-10 consecutive days (as per schedule).
PlaceboDrug
Also called active drug formulation without BWC0977
SAD Cohorts: Two participants in each cohort will receive a matching placebo. MAD Cohorts: Two participants in each cohort will receive a 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: 750 mg and 1500 mg.
MAD Cohorts: Subjects will receive multiple doses of BWC0977 via IV infusion over 30 minutes to 2 hours for 7-10 consecutive days (as per the schedule). Up to four dose groups will be studied. Planned doses and frequencies will be confirmed based on the safety, tolerability, and PK data of BWC0977 obtained in SAD and previous MAD Cohorts Receives: Drug: BWC0977; Drug: Placebo |
| Placebo | Placebo comparator | The placebo used during this study is an active drug formulation without BWC0977.
SAD Cohorts: Subjects will receive single infusions of placebo in 0.45% sodium chloride for injection over two hours.
MAD Cohorts: Subjects will receive multiple infusions of placebo in 0.45% sodium chloride for injection over 30 minutes - 2 hours for 7-10 consecutive days (as per schedule). Frequency of infusions will be determined based on safety, tolerability, and PK data obtained for BWC0977 in SAD and previous MAD Cohorts. Receives: Drug: BWC0977; 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).
Description: 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 8 days MAD: Up to 16 days
Secondary outcomes (17)
AUC[0-t] of BWC0977 following single dose administration
Area under the plasma concentration curve from time zero to last time of quantifiable concentration (AUC0-t) of BWC0977 following single dose administration
Measured: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
AUC[0-inf] of BWC0977 following single dose administration
Area under the plasma concentration curve from time zero to infinity (AUC0-inf) of BWC0977 following single dose administration
Measured: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
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: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
Cmax of BWC0977 following single dose administration
Maximum observed plasma concentration (Cmax) of BWC0977 following single dose administration
Measured: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
Cmax of BWC0977 following repeated dose administration
Maximum observed plasma concentration (Cmax) of BWC0977 following repeat dose administration
Measured: Immediately before (within 60 minutes before) the start of the first infusion and at 5,15, 30, 60, 75, and 90 minutes, 2, 4, 6, and 8, 12, 24 hours after the start of the last infusion on Day 1 and 7 (MAD 1 cohort) or 10 (For MAD2 -MAD4 cohort).
Termianl Half life (T1/2) of BWC0977 following single dose administration
Terminal half-life (T1/2) of BWC0977 following single dose administration
Measured: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
Systemic clearance (CL) following single dose administration
Systemic clearance (CL) of BWC0977 following single dose administration
Measured: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
Volume of distribution at steady state (Vdss) following single dose administration
Volume of distribution at steady state (Vdss) of BWC0977 following single dose
Measured: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
Pre-dose (trough) concentration (Ct) at the end of the dosing interval
Pre-dose (trough) concentration (Ct) at the end of the dosing interval of BWC0977 following repeat dose administration
Measured: Immediately before (within 60 minutes before) the start of the first infusion and at 5,15, 30, 60, 75, and 90 minutes, 2, 4, 6, and 8, 12, 24 hours after the start of the last infusion on Day 1 and 7 (MAD 1 cohort) or 10 (For MAD2 -MAD4 cohort).
Volume of distribution at steady state following repeat dose administration
Volume of distribution at steady state (Vdss) of BWC0977 following repeat dose
Measured: Immediately before (within 60 minutes before) the start of the first infusion and at 5,15, 30, 60, 75, and 90 minutes, 2, 4, 6, and 8, 12, 24 hours after the start of the last infusion on Day 1 and 7 (MAD 1 cohort) or 10 (For MAD2 -MAD4 cohort).
Observed accumulation ratio following repeat dose administration
Observed accumulation ratio (Ro) of BWC0977 following repeat dose administration
Measured: Immediately before (within 60 minutes before) the start of the first infusion and at 5,15, 30, 60, 75, and 90 minutes, 2, 4, 6, and 8, 12, 24 hours after the start of the last infusion on Day 1 and 7 (MAD 1 cohort) or 10 (For MAD2 -MAD4 cohort).
Amount excreted in urine (Ae) following repeat dose administration
Amount excreted in urine (Ae) of BWC0977 following repeat dose administration
Measured: Day 1 pre-dose, 0-8 hours post infusion start Day 7 (MAD1 Cohort): 0-12 hours post infusion start Day 10 (MAD 2-3 cohort): 0-12 hours post infusion start Day 10 (MAD 4 Cohort): 0-8 hours post infusion start
Amount excreted in urine (Ae) following single dose administration
Amount excreted in urine (Ae) of BWC0977 following single dose administration
Measured: 0-4, 4-8, >8-12, >12-24 hours (Days 1-2), >24-36, and >36-48 hours (Days 2-3) after the start of the study drug infusion.
Fraction of the dose excreted in urine (fe) following single dose administration
Fraction of the dose excreted in urine (fe) of BWC0977 following single dose administration
Measured: 0-4, 4-8, >8-12, >12-24 hours (Days 1-2), >24-36, and >36-48 hours (Days 2-3) after the start of the study drug infusion.
Fraction of the dose excreted in urine (fe) following repeat dose administration
Fraction of the dose excreted in urine (fe) of BWC0977 following repeat dose administration
Measured: Day 1 pre-dose, 0-8 hours post infusion start Day 7 (MAD1 Cohort): 0-12 hours post infusion start Day 10 (MAD 2-3 cohort): 0-12 hours post infusion start Day 10 (MAD 4 Cohort): 0-8 hours post infusion start
Renal Clearance (CLr) following single dose administration
Renal Clearance (CLr) of BWC0977 following single dose administration
Measured: 0-4, 4-8, >8-12, >12-24 hours (Days 1-2), >24-36, and >36-48 hours (Days 2-3) after the start of the study drug infusion.
Renal Clearance (CLr) following repeat dose administration
Renal Clearance (CLr) of BWC0977 following repeat dose administration
Measured: Day 1 pre-dose, 0-8 hours post infusion start Day 7 (MAD1 Cohort): 0-12 hours post infusion start Day 10 (MAD 2-3 cohort): 0-12 hours post infusion start Day 10 (MAD 4 Cohort): 0-8 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 posted19 Jun 2025
- Study start10 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bugworks Research Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nucleus Network Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029932
- Sponsor's protocol ID
- C003-2025-01
- Other IDs
- 224842/Z/21/Z, HHS/BARDA OTA No. 75A50122C000
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. 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
- NCT07029932
- Acronym / sponsor ID
- C003-2025-01
- Conditions
- Infectious Diseases, Antimicrobial Drug Resistance
- Keywords
- safety, Tolerability, Pharmacokinetics, BWC0977
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Bugworks Research Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nucleus Network Ltd
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 19 Jun 2025 (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, tolerability, and pharmacokinetics 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 in 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 - 2 will receive one dose of BWC0977 or placebo. In MAD, participants in cohorts 3 - 7 will receive multiple doses of BWC0977 or placebo for 7-10 consecutive days (as per the schedule). In both parts, sequential cohorts will be exposed to increasing doses of BWC0977.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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: BWC0977, Drug: PlaceboSAD Cohorts: Subjects will receive single doses of BWC0977 via IV infusion over 2 hours. Planned doses to be studied are: 750 mg and 1500 mg. MAD Cohorts: Subjects will receive multiple doses of BWC0977 via IV infusion over 30 minutes to 2 hours for 7-10 consecutive days (as per the schedule). Up to four dose groups will be studied. Planned doses and frequencies will be confirmed based on the safety, tolerability, and PK data of BWC0977 obtained in SAD and previous MAD Cohorts |
| Placebo | Placebo comparator | Drug: BWC0977, Drug: PlaceboThe placebo used during this study is an active drug formulation without BWC0977. SAD Cohorts: Subjects will receive single infusions of placebo in 0.45% sodium chloride for injection over two hours. MAD Cohorts: Subjects will receive multiple infusions of placebo in 0.45% sodium chloride for injection over 30 minutes - 2 hours for 7-10 consecutive days (as per schedule). Frequency of infusions will be determined based on safety, tolerability, and PK data obtained for BWC0977 in SAD and previous MAD Cohorts. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Age: Healthy male or female 18 to 55 years of age, inclusive, at time of consent
- Body mass index (BMI): BMI ≥ 19.0 and ≤ 30.0 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive)
- Health Status: Medically healthy without significant history of any chronic diseases or conditions (such as cardiovascular, renal, hepatic, neurological, hematological, gastrointestinal, endocrine, or musculoskeletal disorders). Volunteers must have no clinically significant abnormalities in medical history, as determined by the Investigator.
- Screening Tests:
- Informed consent: Willing and able to provide written informed consent
Key exclusion criteria (16 listed)
- 4) Electrocardiographic abnormalities: Baseline QTcF of >450 msec (for males), and >470 msec (for females) at screening or check-in (Day-1) 5) Photosensitivity: History of photosensitivity to quinolones 6) Clostridium Difficile: History of known or suspected Clostridium difficile infection 7) Hospitalization History: Any condition that necessitated hospitalization within the 3 months prior to Day -1 or is likely to require so during the study 8) Antibiotic History: No systemic antibiotic use within 5 days before dosing. 9) Infection History: 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) at screening.
- 10) Recent Medications: Exclude participants receiving all prescription and OTC medications (except hormonal contraception and Paracetamol) 14 days or 5 half-lives, whichever is longer, prior to IP dosing.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, paracetamol (a maximum of 4 doses per day of 500 mg, and no more than 3 g per week) for the treatment of headache or any other pain as per the PI's judgement.
- 11) Hypersensitivity: DocumentedHistory of significant hypersensitivity reaction or anaphylaxis to any medication, as determined by the Medical Officer.
- 12) Tobacco and Nicotine Use: Smoker (including tobacco, e-cigarettes, or marijuana) or nicotine user within 1 month prior to dosing and have a positive test for cotinine at check in on Day -1 (may be repeated once, at the discretion of the Investigator or Medical officer, in the instance of a positive result).
- 13) Drug/Alcohol Abuse: Positive urine drug/alcohol breath 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 Investigator or Medical officer, in the instance of a positive result).
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 and previous MAD cohorts. Daily dosing will continue for a total of 7-10 consecutive days (as per schedule). | Drug | BWC0977, Placebo |
| PlaceboAlso: active drug formulation without BWC0977SAD Cohorts: Two participants in each cohort will receive a matching placebo. MAD Cohorts: Two participants in each cohort will receive a matching placebo. | Drug | BWC0977, 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 8 days MAD: Up to 16 days
Description: 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.
17 secondary outcomes
AUC[0-t] of BWC0977 following single dose administration
Time frame: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
AUC[0-inf] of BWC0977 following single dose administration
Time frame: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
AUC[0-8], AUC[0-12], AUC[0-24] of BWC0977 following single dose administration
Time frame: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
Cmax of BWC0977 following single dose administration
Time frame: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
Cmax of BWC0977 following repeated dose administration
Time frame: Immediately before (within 60 minutes before) the start of the first infusion and at 5,15, 30, 60, 75, and 90 minutes, 2, 4, 6, and 8, 12, 24 hours after the start of the last infusion on Day 1 and 7 (MAD 1 cohort) or 10 (For MAD2 -MAD4 cohort).
Termianl Half life (T1/2) of BWC0977 following single dose administration
Time frame: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
Systemic clearance (CL) following single dose administration
Time frame: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
Volume of distribution at steady state (Vdss) following single dose administration
Time frame: Immediately before (within 60 minutes before) the start of infusion of the study drug and 5, 10,15, 20, 30, 45, 60, 75, and 90 minutes, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours after the start of study drug infusion.
Pre-dose (trough) concentration (Ct) at the end of the dosing interval
Time frame: Immediately before (within 60 minutes before) the start of the first infusion and at 5,15, 30, 60, 75, and 90 minutes, 2, 4, 6, and 8, 12, 24 hours after the start of the last infusion on Day 1 and 7 (MAD 1 cohort) or 10 (For MAD2 -MAD4 cohort).
Volume of distribution at steady state following repeat dose administration
Time frame: Immediately before (within 60 minutes before) the start of the first infusion and at 5,15, 30, 60, 75, and 90 minutes, 2, 4, 6, and 8, 12, 24 hours after the start of the last infusion on Day 1 and 7 (MAD 1 cohort) or 10 (For MAD2 -MAD4 cohort).
Observed accumulation ratio following repeat dose administration
Time frame: Immediately before (within 60 minutes before) the start of the first infusion and at 5,15, 30, 60, 75, and 90 minutes, 2, 4, 6, and 8, 12, 24 hours after the start of the last infusion on Day 1 and 7 (MAD 1 cohort) or 10 (For MAD2 -MAD4 cohort).
Amount excreted in urine (Ae) following repeat dose administration
Time frame: Day 1 pre-dose, 0-8 hours post infusion start Day 7 (MAD1 Cohort): 0-12 hours post infusion start Day 10 (MAD 2-3 cohort): 0-12 hours post infusion start Day 10 (MAD 4 Cohort): 0-8 hours post infusion start
Amount excreted in urine (Ae) following single dose administration
Time frame: 0-4, 4-8, >8-12, >12-24 hours (Days 1-2), >24-36, and >36-48 hours (Days 2-3) after the start of the study drug infusion.
Fraction of the dose excreted in urine (fe) following single dose administration
Time frame: 0-4, 4-8, >8-12, >12-24 hours (Days 1-2), >24-36, and >36-48 hours (Days 2-3) after the start of the study drug infusion.
Fraction of the dose excreted in urine (fe) following repeat dose administration
Time frame: Day 1 pre-dose, 0-8 hours post infusion start Day 7 (MAD1 Cohort): 0-12 hours post infusion start Day 10 (MAD 2-3 cohort): 0-12 hours post infusion start Day 10 (MAD 4 Cohort): 0-8 hours post infusion start
Renal Clearance (CLr) following single dose administration
Time frame: 0-4, 4-8, >8-12, >12-24 hours (Days 1-2), >24-36, and >36-48 hours (Days 2-3) after the start of the study drug infusion.
Renal Clearance (CLr) following repeat dose administration
Time frame: Day 1 pre-dose, 0-8 hours post infusion start Day 7 (MAD1 Cohort): 0-12 hours post infusion start Day 10 (MAD 2-3 cohort): 0-12 hours post infusion start Day 10 (MAD 4 Cohort): 0-8 hours post infusion start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Balasubramanian V, PhD contact
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 Antimicrobial Drug Resistance, 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 20 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harish Kaushik Kotakonda, PhD (+91-9550288659, harish@bugworksresearch.com), or a site near the patient. 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 8 days MAD: Up to 16 days). 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 30 Sep 2026.