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Can a new injection tame hemophilia a bleeding?

NCT ID NCT07787091

Disease control Sponsor: Arditus Pte Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This study tests an investigational medicine called ARD001, designed to treat hemophilia A, a bleeding disorder. In the first phase, healthy adults receive a single dose of ARD001 or a placebo to check safety and how the drug behaves in the body. If that goes well, a second phase will give repeated doses to adults with hemophilia A to see if it can help control bleeding. The goal is to find out if ARD001 is safe and to identify doses for future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ARD001, an investigational biologic given as an injection under the skin
What this could lead to
If successful, ARD001 could offer a new treatment option for hemophilia A, potentially reducing bleeding episodes and improving quality of life.
What could go wrong
This is an early-stage trial. The safety and effectiveness of ARD001 are not yet established, and it may not work as hoped or could cause 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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

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

21 to 45 years

Sex

Male participants only

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.

Phase 1 Inclusion Criteria: * Healthy adults within the specified age and body-weight ranges * Able and willing to provide informed consent * Considered healthy based on medical history, physical examination, vital signs, electrocardiogram and laboratory assessments * Other essential criteria from the approved protocol Phase 1 Exclusion Criteria: * History of severe drug or food allergy, or known allergy to ARD001 or its components * Acute infection within 14 days before dosing or fever on the planned dosing day * Clinically significant cardiovascular, coagulation, hepatic, renal or other medical abnormality * Recent use of prohibited medications within the protocol-defined washout periods * Other major exclusions from the approved protocol

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Conditions

The condition(s) this trial relates to.

hemophilia A thrombotic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy adult participants Hemophilia A

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • SingHealth Investigational Medicine Unit

    RECRUITING

    Singapore, Singapore

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