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Hmb-001

Clinical trials are investigating Hmb-001 in people with Glanzmann Thrombasthenia, a rare bleeding disorder. The study is looking at safety, tolerability, dosing, and early signs of benefit on bleeding. It includes different trial parts to help choose doses and repeat-dose schedules.

Table of contents

Trial overview

The clinical trial NCT06211634 is studying Hmb-001 in people with Glanzmann Thrombasthenia, a rare bleeding disorder.[1] The study is authorised and plans to enroll 41 participants.[1]

This trial is interventional, which means participants receive the study treatment so researchers can observe what happens.[1] The treatment is given by subcutaneous administration, meaning it is given under the skin.[1]

Study design and phase

This is a Phase 1/2 trial.[1] Phase 1 studies mainly focus on safety and tolerability, while Phase 2 studies also look for early signs that a treatment may help.[1]

The study has three parts: Part A, Part B, and Part C.[1] Part A is used to determine safe dose levels and dosing intervals for later parts of the study.[1]

Who can participate

The trial is designed for participants with Glanzmann Thrombasthenia.[1] The source data does not list all eligibility rules, so the full entry criteria are not shown here.[1]

In studies like this, eligibility usually depends on the study’s detailed rules, which are checked by the research team.[1]

What is being measured

The main safety checks include the number of treatment-emergent adverse events, which are new or worsening problems that happen after treatment starts.[1] Researchers also track changes in physical examinations, vital signs, clinical laboratory tests, and ECG results, which measure the heart’s electrical activity.[1]

For Parts B and C, the study also looks at early signs of benefit on bleeding.[1] These measures include the annualized treated bleed rate and the annualized bleed rate, which estimate how often bleeding happens over one year.[1]

The brief study summary also says the trial will estimate the preliminary prophylactic effect of Hmb-001 on bleeding frequency and bleeding severity.[1] “Prophylactic” means used to help prevent bleeding episodes before they happen.[1]

Why the study has parts A, B, and C

Part A is the first step and is focused on finding the dose level or levels and dosing interval or intervals to test later.[1] This helps researchers choose a study plan for the next parts of the trial.[1]

Parts B and C then repeat dosing to confirm the safety and tolerability profile of Hmb-001.[1] These parts also look for early signs that the treatment may lower bleeding frequency and bleeding severity.[1]

What the trial may help researchers learn

This study is designed to answer practical questions about Hmb-001 in a rare bleeding disorder, not to give a final answer about long-term benefit.[1] The main goals are to see whether the treatment can be given safely, how it behaves in the body, and whether it shows early signs of helping with bleeding.[1]

Because the trial is still early, the results will mainly help guide future research rather than prove how well the treatment works on its own.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06211634 Phase 1/2 Glanzmann Thrombasthenia Authorised 41

FAQ

  • What is Hmb-001 being studied for? Hmb-001 is being studied in clinical trials for Glanzmann Thrombasthenia. The trial is mainly checking safety, tolerability, and whether it may help reduce bleeding.
  • Who may take part in the trial? The trial is for participants with Glanzmann Thrombasthenia. The source data does not list all entry rules, so exact participation depends on the study team’s criteria.
  • What phase is the Hmb-001 trial? This study is a Phase 1/2 trial. That means it is early research that looks at safety first and also checks early signs of how well the treatment may work.
  • What are the researchers measuring? Researchers are measuring safety through side effects, physical exams, vital signs, lab tests, and ECGs. They are also looking at bleeding frequency, including annualized treated bleed rate and annualized bleed rate.
  • Why does the trial have parts A, B, and C? Part A is used to find safe dose levels and dosing intervals. Parts B and C then test repeat dosing and look for early signs that Hmb-001 may lower bleeding.

Ongoing Clinical Trials on Hmb-001

  • Study on the Safety and Effects of HMB-001 for Patients with Glanzmann Thrombasthenia

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Italy The Netherlands

Glossary

  • Glanzmann Thrombasthenia: A rare bleeding disorder. People with this condition can have trouble forming stable blood clots, which can lead to more bleeding.
  • Phase 1/2: An early stage of clinical research. Phase 1 focuses on safety, and Phase 2 also looks for early signs that the treatment may help.
  • Interventional study: A trial where participants receive a study treatment so researchers can measure its effects.
  • Safety: How well a treatment is tolerated and whether it causes unwanted effects or changes in test results.
  • Tolerability: How manageable the treatment is for participants, especially in terms of side effects and overall comfort.
  • Pharmacokinetics (PK): How the body absorbs, moves, and removes a treatment.
  • Pharmacodynamics (PD): How a treatment affects the body and what changes it causes.
  • Treatment-emergent adverse events: New or worsening medical problems that happen after a participant starts the study treatment.
  • Vital signs: Basic body measurements such as blood pressure, pulse, and temperature.
  • ECG: Electrocardiogram, a test that records the heart’s electrical activity.
  • Annualized treated bleed rate (ATBR): A way to estimate how often treated bleeding episodes happen over one year.
  • Annualized bleed rate (ABR): A way to estimate the total number of bleeding episodes over one year.

References