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Tests treatment safety and results for Infectious Diseases
Official title A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers
ClinicalTrials.gov ID: NCT07029932
What this study is testing
What is BWC0977?
BWC0977 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for infectious diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Screening Tests:
- No findings in Physical examination or vital signs (including temperature, heart rate, respiratory rate, and blood pressure) that the Investigator...
You likely can't join if
- 1) Pregnancy and Lactation: Women who are pregnant and/or lactating. 2) Significant Medical History: History or presence of significant...
- History of any kidney disease or current or chronic history of impaired renal function as indicated by a calculated creatinine clearance...
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert syndrome or asymptomatic gallstones) 3)...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 a) Clinically significant abnormal findings in...
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.