Can a single injection quiet a clotting protein?
NCT ID NCT05653037
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This Phase 1 trial tests a single injection of RBD4059, an experimental RNA drug, in healthy adults aged 18 to 65. The drug targets a clotting protein called FXI, which may lower the risk of blood clots with less bleeding risk than standard treatments. Researchers measure safety, how the drug moves through the body, and its effect on clotting markers. The study uses a placebo for comparison and increases the dose in steps to find a safe level.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RBD4059, an experimental small interfering RNA (siRNA) drug given as a single injection under the skin
- What this could lead to
- If safe and effective, RBD4059 could become a new way to prevent blood clots with fewer bleeding risks than current treatments.
- What could go wrong
- This is an early, small trial focused on safety in healthy people, not on proving the drug works. The drug may not lower clot risk as hoped or could cause unexpected side effects.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
32 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Nov 2025
- 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
-
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: * Male and female (non-childbearing potential only), aged 18 to 65 years, inclusive. * Body mass index (BMI) between 18 and 32 kg/m2, inclusive. * APTT, Prothrombin time(PT), INR, thrombin time (TT),FXI activity must be within the normal reference range (as per the local laboratory reference range) at screening . * Adequate complete blood counts (CBCs) and platelet are within the normal reference range (If CBCs are outside the reference range, unless not clinically significant determined by the Investigator ). * Healthy as determined by pre-study medical history, vital signs, physical examination, clinical laboratory assessments, and 12-lead electrocardiogram (ECG). * Subjects who are willing to cooperate with the study staff, comply with the study requirements, complete the study according to the relevant procedures specified in the protocol, and correctly understand and sign the informed consent form in writing. Exclusion Criteria: * Any uncontrolled or serious disease that may interfere with participation in the clinical study and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical study. * History or presence of cardiovascular disease (including peripheral artery and cerebrovascular disease). * Systolic blood pressure (SBP) is less than 90 or greater than 140 mmHg and/or diastolic blood pressure (DBP) is less than 40 or greater than 90 mmHg after 10 minutes of supine rest, unless determined by the Investigator to be not clinically significant. * Diagnosis of diabetes mellitus, history of gestational diabetes that is fully resolved is not permitted. * Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study. Note: additional inclusion/exclusion criteria may apply, per protocol.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Q-Pharm Pty Limited
Brisbane, Australia
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