A Phase 1 Clinical Study in Healthy Participants (NCT07584876) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase 1 Clinical Study in Healthy Participants
Australia40 participantsStarted 2026-05-15
Plain-language summary
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-41012 in Healthy Participants
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Must have given written informed consent and be able to comply with all study requirements
* Males or females aged 18 to 65 years old, inclusive, at the time of informed consent
* Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 and body weight ≥50.0 kg.
* APTT, PT, INR, and FXI activity within the normal range at screening
* Agree to avoid activities that can increase the risk of severe bleeding
* Female participants must be non-pregnant
* Male participants with female partners of child-bearing potential must agree to use acceptable methods of contraception from screening until 360 days following administration of the study drug
Exclusion Criteria:
* Any clinically significant chronic medical condition or clinically significant abnormality in laboratory parameters
* Any skin condition and/or tattoo
* Hospitalization for any reason within 60 days prior to screening
* History or presence of cancer
* Any clinically significant acute condition
* Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after at least 5 minutes resting
* Clinical laboratory findings outside of range
* Any liver function panel analyte value \> 1.2 × upper limits of normal (ULN)
* Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody
* Single 12-lead ECG with clinically significant abnormalities at screening or Day -1
* Use of an investigational agent
* .Used of prescription drugs
* History or clinical evidence of alcohol substance a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.