Actively Recruiting
A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers
Led by Bugworks Research Inc. · Updated on 2025-11-24
48
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
Sponsors
B
Bugworks Research Inc.
Lead Sponsor
N
Nucleus Network Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males or females aged 18 to 55 years at the time of consent
- Body mass index (BMI) between 19.0 and 30.0 kg/m2 and weight between 55.0 and 100.0 kg
- Medically healthy without significant chronic diseases or conditions as determined by the Investigator
- No abnormal findings in physical exam, vital signs, or triplicate ECGs (QTcF ≤450 msec for males, ≤470 msec for females) that interfere with study results
- Willing and able to provide written informed consent
- Agree to be available for all study visits and follow study protocol
- Willing to refrain from strenuous physical activity including contact sports from 4 days prior to admission until study completion
- Have suitable venous access for drug administration and blood sampling
- Agree to contraception requirements if of reproductive potential, including use of two effective methods for females or condom plus another method for males, or complete sexual abstinence during and after the study as specified
You will not qualify if you...
- Women who are pregnant or lactating
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, musculoskeletal, dermatologic, or neurological diseases, including acute illness or surgery within past 3 months
- History of kidney disease or impaired renal function (creatinine clearance <80 mL/min)
- Current or chronic liver disease or abnormalities (except Gilbert syndrome or asymptomatic gallstones)
- Clinically significant abnormal lab results at screening or check-in
- Baseline QTcF >450 msec (males) or >470 msec (females) at screening or check-in
- History of photosensitivity to quinolones
- History of Clostridium difficile infection
- Hospitalization within 3 months prior to Day -1 or likely during study
- Use of systemic antibiotics within 5 days before dosing
- Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibodies
- Use of prescription or OTC medications (except hormonal contraception and paracetamol) within 14 days or 5 half-lives before dosing
- History of significant hypersensitivity or anaphylaxis to any medication
- Use of tobacco, nicotine, or marijuana within 1 month prior to dosing and positive cotinine test
- Positive urine drug or alcohol test or history of substance or alcohol abuse within past 5 years
- Recent blood or plasma donation or blood transfusion within specified timeframes
- Previous participation in this study or other studies with study drug within specified timeframes
- Consumption of certain citrus fruits and juices within 7 days prior to dosing
- Employment or family relationship with Sponsor, clinical research unit, or study organization
- Unable or unwilling to comply fully with study requirements
- Any other medical condition judged by Investigator to preclude participation or increase risk
- Consumption of poppy seed-containing foods within 48 hours prior to screening and Day -1 to avoid false positive drug tests
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nucleus Network
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
H
Harish Kaushik Kotakonda, PhD
CONTACT
B
Balasubramanian V, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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