Actively Recruiting
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
Led by Bugworks Research Inc. · Updated on 2025-11-24
48
Participants Needed
1
Research Sites
8 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
Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drug's safety profile. Participants will be divided into two main groups: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.
CONDITIONS
Brief 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 clinically significant abnormalities
- Normal physical exam and vital signs without findings that interfere with study results
- Triplicate ECGs without clinically significant abnormalities including QTcF interval limits
- Willing and able to provide written informed consent
- Willing to comply with all study visits and protocol requirements
- Willing to avoid strenuous physical activity causing muscle aches or injury from 4 days before admission until study completion
- Suitable venous access for drug administration and blood sampling
- Females of reproductive potential must use two forms of effective contraception or agree to sexual abstinence during the study and for 33 days after last dose
- Males with female partners of childbearing potential must use condoms plus another birth control method or agree to abstinence during the study and for 93 days after last dose
- Participants must agree not to donate eggs or sperm during the study and specified post-study periods
You will not qualify if you...
- Pregnant or lactating women
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, musculoskeletal, dermatologic, neurological, or psychiatric disorders
- History of kidney disease or impaired renal function with creatinine clearance <80 mL/min
- Liver disease or known hepatic/biliary abnormalities except Gilbert syndrome or asymptomatic gallstones
- Clinically significant abnormal lab results or elevated liver enzymes above normal limits
- Baseline ECG abnormalities with QTcF >450 msec (males) or >470 msec (females)
- History of photosensitivity to quinolones
- History of Clostridium difficile infection
- Hospitalization within 3 months prior to study or expected hospitalization during the study
- Systemic antibiotic use within 5 days before dosing
- Positive tests for hepatitis B surface antigen, hepatitis C antibodies, 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
- Tobacco or nicotine use within 1 month before dosing with positive cotinine test
- Positive urine drug or alcohol test or history of substance or alcohol abuse in past 5 years
- Recent blood or plasma donation or transfusion within specified time frames
- Previous participation in this study or other studies within 30 days or 5 half-lives of the agent
- Consumption of certain citrus fruits or juices seven days prior to dosing
- Employment or family relation to study sponsor or research sites
- Inability or unwillingness to comply with study protocol
- Any other medical condition that may pose risk or interfere with participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 days
Participants receive a single intravenous dose of BWC0977 or placebo. Dosing occurs over 2 hours. This phase includes dose escalation with sequential cohorts receiving increasing doses.
1 dosing visit and multiple post-dose assessments up to 48 hours
Duration - 7 to 10 days
Participants receive multiple daily intravenous doses of BWC0977 or placebo for 7 to 10 consecutive days. Infusions last between 30 minutes to 2 hours depending on dosing schedule. Dose escalation occurs across sequential cohorts.
Daily dosing visits for 7 to 10 days with pharmacokinetic blood sampling
Duration - Up to 8 days after last dose
Participants are monitored for safety and tolerability after completing dosing.
Several follow-up visits for safety assessments
Trial Site Locations
Total: 1 location
1
Nucleus Network
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
H
Harish Kaushik Kotakonda, PhD
B
Balasubramanian V, PhD
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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