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HMB-001

Phase 1

Glanzmann Thrombasthenia | Small molecule | Hematology |Hemab Therapeutics Holdings, Inc.|Last Updated: Dec 24, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment57

FDA Designations

No designations recorded

Clinical trial landscape

HMB-001 · 1 trial · 1 indication

Phase 1 1
NCT06211634A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann ThrombastheniaGlanzmann Thrombasthenia
ACTIVE NOT_RECRUITING57 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia
Glanzmann Thrombasthenia
NCT0621163457
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Study Endpoints

Primary Endpoints

Part A: Safety as assessed by the incidence of treatment-emergent adverse events (TEAEs)
From baseline to Day 57
Part A: Safety as assessed by the changes in physical examinations, vital signs, clinical laboratory assessments, and ECG parameters
From baseline to Day 57
Part B: Safety as assessed by the incidence of treatment-emergent AEs
From baseline to Day 106/Early Termination (ET)/End of Study (EOS)
Part B: Safety as assessed by the changes in physical examinations, vital signs, clinical laboratory assessments, and ECG parameters
From baseline to Day 106/ET/EOS
Part B: Preliminary prophylactic effect of HMB-001 as assessed via Bleed frequency: annualized bleed rate (ABR)
From baseline to Day 106/ET/EOS
Part B: Preliminary prophylactic effect of HMB-001 as assessed via Bleed frequency: annualized treated bleed rate (ATBR)
From baseline to Day 106/ET/EOS
Part C: Safety as assessed by the incidence of treatment-emergent AEs
Day 99 to Day 687/Early Termination (ET)/ENdo of Study (EOS)
Part C: Safety as assessed by the changes in physical examinations, vital signs, clinical laboratory assessments, and ECG parameters
Day 99 to Day 687/Early Termination (ET)/ENdo of Study (EOS)
Part C: Preliminary prophylactic effect of HMB-001 as assessed via Bleed frequency: annual treated bleed rate (ATBR) and annualized bleed rate (ABR)
Day 99 to Day 687/Early Termination (ET)/ENdo of Study (EOS)

Secondary Endpoints

Part A: Plasma concentrations of HMB-001
From baseline to Day 57
Part A: Pharmacokinetics (PK) parameters: Maximum observed plasma concentration (Cmax)
From baseline to Day 57
Part A: PK parameters: Area under the curve from time zero to last quantifiable concentration (AUClast)
From baseline to Day 57
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Single or Multiple ascending dose of HMB-001EXPERIMENTALOpen-label, single or multiple ascending dose of HMB-001

Interventions

NameTypeDescription
HMB-001DRUGHMB-001 is a bispecific antibody being developed as a prophylactic treatment option to prevent and reduce bleeding events in patients with Glanzmann thrombasthenia.
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Eligibility Criteria

Age Range18 Years to 67 Years
SexALL
Healthy VolunteersNo
Study Sites17

Part A Inclusion Criteria: 1. Age 18 to 65 years, at the time of signing informed consent. 2. Glanzmann thrombasthenia; documented abnormal, diagnostic platelet aggregometry plus deficiency of the αIIbβ3 (GPIIb/GPIIIa) receptor via flow cytometry; or genetic diagnosis. 3. Has the ability to provide...

Countries:United StatesBelgiumFranceItalyNetherlandsUnited Kingdom
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Frequently asked questions about HMB-001

What is HMB-001 used for?

HMB-001 is an investigational small molecule being developed for the treatment of Glanzmann Thrombasthenia, a rare bleeding disorder. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes HMB-001?

HMB-001 is being developed by Hemab Therapeutics Holdings, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol COAG.

What phase is HMB-001 in?

HMB-001 is currently in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The ongoing study is a Phase 1/2 trial investigating the drug in patients with Glanzmann Thrombasthenia.

What clinical trials is HMB-001 in?

HMB-001 is being studied in a Phase 1/2 clinical trial with the identifier NCT06211634. This trial is investigating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of HMB-001 in patients with Glanzmann Thrombasthenia. The study is active but not recruiting participants.

How does HMB-001 work?

HMB-001 is a small molecule therapeutic. Its specific molecular target has not been disclosed in available information, so its precise mechanism of action in treating Glanzmann Thrombasthenia is not publicly detailed.