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A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia
NCT06211634 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this clinical trial is to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Participants with Glanzmann Thrombasthenia. The main questions it aims to answer are: * Parts A, B, and C: To determine the safety and tolerability of HMB-001 * Part A: To establish the dose level(s) and dosing interval(s) of HMB-001 to be investigated in Parts B and C * Parts B and C: To estimate the ability of HMB-001 to prevent the number and severity of bleeds Part A will assess differing singular doses of HMB-001 in small groups of participants. The dose administered to a newly enrolled participant (or groups of participants) may only increase if analysis of data from previous dosing shows it is safe to do so. The planned duration of participation in Part A is approximately 6 months, which consists of a Screening Period, an optional Run-in Observation Period, and a follow-up period of 8 weeks. Part B is similar to Part A as it involves testing different dose levels of HMB-001 in small groups of participants. However, in Part B, HMB-001 is given multiple times over a 3-month period, either weekly, every 2 weeks, or every 4 weeks. Part B consists of a Screening Period, a Run-in Observation Period, a 3-month Treatment Period, and a Safety Follow-up following the last dose of HMB-001. Part C is open to participants from Part B and consists of approximately a 18-month Treatment Period and a Safety Follow-up following the last dose of HMB-001.
Conditions Studied
Interventions
- DRUG HMB-001
Study Locations (17)
Other
- University Hospital Leuven - Campus Gasthuisberg (Part B/C) — Leuven
- AP-HP Hopital Bicetre (Part B/C) — Le Kremlin-Bicêtre
- AP-HM - Hopital de la Timone — Marseille
- AP-HP Hopital Necker-Enfants Malades (Part B/C) — Paris
- Azienda Ospedaliero-Universitaria Careggi (Part B/C) — Florence
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano (Part B/C) — Milan
- Universitair Medisch Centrum Utrecht (Part B/C) — Utrecht
- Queen Elizabeth Hospital Birmingham (Part B/C) — Birmingham
- Leeds Teaching Hospitals NHS Trust — Leeds
- Richmond Pharmacology Ltd (Part A/B/C) — London
- Royal Free London NHS Foundation Trust (Part B/C) — London
- The Royal London Hospital (Part B/C) — Whitechapel
California
- University of California, San Diego (UCSD) (Part B/C) — La Jolla
Louisiana
- Tulane University Medical Center (Part B/C) — New Orleans
Minnesota
- Mayo Clinic - Rochester (Part B/C) — Rochester
Pennsylvania
- Hemophilia Center of Western Pennsylvania (HCWP) (Part B/C) — Pittsburgh
Washington
- Washington Institute for Coagulation (Part B/C) — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2022-12-13 |
| Est. Completion | 2027-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06211634
The ClinicalTrials.gov registry entry for NCT06211634 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hemab ApS, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Glanzmann Thrombasthenia appearing as the primary indexed condition, and to 1 intervention — of which HMB-001 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06211634 reports 17 study locations spanning 6 distinct geographic areas — top geographies include Other, California, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06211634 about?
NCT06211634 is a clinical study titled "A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia". The goal of this clinical trial is to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Participants with Glanzmann Thrombasthenia. The main questions it aims to answer are: * Parts A, B, and C: To determine the safety and tolerability of HMB-001 ...
What is the current status of trial NCT06211634?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2022-12-13. Estimated completion is 2027-08.
What conditions does trial NCT06211634 study?
This clinical trial studies the following conditions: Glanzmann Thrombasthenia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06211634?
The interventions under investigation include: HMB-001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06211634?
This trial is sponsored by Hemab ApS, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06211634 being conducted?
This trial has 17 study locations across California, Louisiana, Minnesota, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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