New drug BW-41012 enters first human safety tests
NCT ID NCT07584876
First seen Jun 24, 2026 · Last updated Jul 10, 2026 · Updated 3 times
Summary
This early-phase trial will test the safety and tolerability of a single injection of BW-41012 in 40 healthy adults aged 18 to 65. Participants will be randomly assigned to receive either the drug or a placebo, and researchers will monitor for side effects and measure how the drug behaves in the body. The study does not aim to treat any disease, but to gather essential safety data before moving to patient trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BW-41012 (injection)
- What could go wrong
- This is a very early, small study in healthy people, not patients. It only checks safety and how the drug moves in the body, not whether it works for any disease. Many early-stage drugs fail to show benefit later.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Argo Investigative Site
RECRUITINGPerth, Western Australia, Australia
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