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Can a single injection of HMB-003 be safe for humans? a first test begins

NCT ID NCT07798505

Knowledge-focused Sponsor: Hemab ApS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 11, 2026 · Updated 5 times

Summary

Researchers are testing a new experimental drug called HMB-003 in healthy adults aged 18 to 50. The goal is to see how well the body tolerates a single injection and to measure how much of the drug stays in the blood and urine. This first-in-human study focuses on safety and how the drug behaves, not yet on treating any disease.

What this could mean

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

Active substance
HMB-003, an experimental drug given as a single subcutaneous injection
What this could lead to
If HMB-003 proves safe and well tolerated, it could pave the way for further studies to see if it helps treat blood clotting disorders.
What could go wrong
This is an early, first-in-human study with only 40 healthy volunteers. The drug may cause side effects or fail to show the desired effects in later trials.

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

About 40 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

Apr 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

18 to 50 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: * Participant is aged 18 to 50 years, inclusive, at the time of signing informed consent. * Overall healthy as determined by medical evaluation including physical examination, vital signs, laboratory tests, and ECG. Exclusion Criteria: * Participant has a history of clinically significant hypersensitivity to any excipients of the study drug * Participant is pregnant, breastfeeding, or \<6 weeks postpartum. * Participant has received investigational drug or device in another clinical study within 30 days or 5 half-lives, whichever is longer, before dosing.

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As listed by the trial registrant

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

Healthy adult participants

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

  • Worldwide Clinical Trials

    RECRUITING

    San Antonio, Texas, 78217, United States

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