Can a single injection quiet a clotting protein?

NCT ID NCT05653037

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Mar 2023

Finished

Nov 2025

Lead sponsor

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Q-Pharm Pty Limited

    Brisbane, Australia

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