BridgeMD
New treatment option for HV
Official title A Phase 1 Clinical Study in Healthy Participants
ClinicalTrials.gov ID: NCT07584876
What this study is testing
- What it's testing
- 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
- 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 65. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 abuse
- History or clinical evidence of drug abuse
- Positive test for alcohol or drugs of abuse at screening or Day -1
- Donated or lost \>200 mL of blood
- .Any conditions which, in the opinion of the Investigator
The study team makes the final eligibility decision.
Where it's taking place
- Perth, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Perth, Western Australia, 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.