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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07029932




Registration number
NCT07029932
Ethics application status
Date submitted
12/06/2025
Date registered
19/06/2025
Date last updated
25/06/2025

Titles & IDs
Public title
A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers
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
Secondary ID [1] 0 0
224842/Z/21/Z
Secondary ID [2] 0 0
C003-2025-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infectious Diseases 0 0
Antimicrobial Drug Resistance 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
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: 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 comparator: Placebo - 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.


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 and previous MAD cohorts. Daily dosing will continue for a total of 7-10 consecutive days (as per schedule).

Treatment: Drugs: Placebo
SAD Cohorts: Two participants in each cohort will receive a matching placebo. MAD Cohorts: Two participants in each cohort will receive a matching placebo.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs and serious adverse events (SAEs) overall and by intensity (Safety and tolerability).
Timepoint [1] 0 0
SAD: Up to 8 days MAD: Up to 16 days
Secondary outcome [1] 0 0
AUC[0-t] of BWC0977 following single dose administration
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
AUC[0-inf] of BWC0977 following single dose administration
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
AUC[0-8], AUC[0-12], AUC[0-24] of BWC0977 following single dose administration
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Cmax of BWC0977 following single dose administration
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
Cmax of BWC0977 following repeated dose administration
Timepoint [5] 0 0
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).
Secondary outcome [6] 0 0
Termianl Half life (T1/2) of BWC0977 following single dose administration
Timepoint [6] 0 0
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.
Secondary outcome [7] 0 0
Systemic clearance (CL) following single dose administration
Timepoint [7] 0 0
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.
Secondary outcome [8] 0 0
Volume of distribution at steady state (Vdss) following single dose administration
Timepoint [8] 0 0
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.
Secondary outcome [9] 0 0
Pre-dose (trough) concentration (Ct) at the end of the dosing interval
Timepoint [9] 0 0
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).
Secondary outcome [10] 0 0
Volume of distribution at steady state following repeat dose administration
Timepoint [10] 0 0
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).
Secondary outcome [11] 0 0
Observed accumulation ratio following repeat dose administration
Timepoint [11] 0 0
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).
Secondary outcome [12] 0 0
Amount excreted in urine (Ae) following repeat dose administration
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
Amount excreted in urine (Ae) following single dose administration
Timepoint [13] 0 0
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.
Secondary outcome [14] 0 0
Fraction of the dose excreted in urine (fe) following single dose administration
Timepoint [14] 0 0
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.
Secondary outcome [15] 0 0
Fraction of the dose excreted in urine (fe) following repeat dose administration
Timepoint [15] 0 0
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
Secondary outcome [16] 0 0
Renal Clearance (CLr) following single dose administration
Timepoint [16] 0 0
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.
Secondary outcome [17] 0 0
Renal Clearance (CLr) following repeat dose administration
Timepoint [17] 0 0
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

Eligibility
Key inclusion criteria
1. Age: Healthy male or female 18 to 55 years of age, inclusive, at time of consent
2. Body mass index (BMI): BMI = 19.0 and = 30.0 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive)
3. 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.
4. Screening Tests:

1. 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
2. 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
3. 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
5. Informed consent: Willing and able to provide written informed consent
6. Compliance: Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of events.
7. 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.
8. Venous Access: Have suitable venous access for drug administration and blood sampling
9. 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 oral contraceptive, implant, a vaginal ring, injectable, indwelling intrauterine device, history of bilateral tubal ligation, sole vasectomized 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 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 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 and follicle-stimulating hormone levels in menopausal range), 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, must agree to use male condom plus 1 other highly effective method of birth control in their partner (e.g., Hormonal oral contraceptive, implant, a vaginal ring, injectable, indwelling intrauterine device, history of bilateral tubal ligation), or agree to complete sexual abstinence for the duration of the study and for 93 days after last study drug administration.

To be considered surgically sterile, male participants must have had a vasectomy at least 3 months before screening with appropriate documentation of the absence of sperm in the ejaculate. The use of condom by male partner will be required if 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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.

1. 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).
2. Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert syndrome or asymptomatic gallstones) 3) Laboratory abnormalities

a) Clinically significant abnormal findings in serum chemistry, hematology, 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 test may be repeated prior to confirming exclusion.

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: Documented hypersensitivity reaction or anaphylaxis to any medication.

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, 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, 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 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.

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.

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2026
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bugworks Research Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Nucleus Network Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Harish Kaushik Kotakonda, PhD
Address 0 0
Country 0 0
Phone 0 0
+91-9550288659
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT07029932