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A Study Assessing HMB-002 in Participants With Von Willebrand Disease

NCT06754852 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-12-09

No results posted yet for this study

Summary

This is a first-in-human (FIH), Phase 1/2, open-label, dose escalation, safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and efficacy study of HMB-002 in participants with VWD. Part A of the study involves a single ascending dose (SAD) design to establish safety, tolerability, PK, and PD effect. In Part B of the study, the safety and tolerability of repeat dosing will be established prior to cohort expansion to explore efficacy.

Conditions

  • Von Willebrand Disease (VWD)
  • Von Willebrand Disease (VWD), Type 1
  • Von Willebrand Disease (VWD), Type 2

Interventions

DRUG

HMB-002 (Part A)

HMB-002 will be administered subcutaneously. Part A will utilize sentinel dosing. The planned duration of study participants in Part A is approximately 12 weeks.

DRUG

HMB-002 (Part B)

HMB-002 will be administered subcutaneously. Part B dosing intervals will be determined following evaluation of Part A results. The planned duration of study participants in Part B will be approximately 21 weeks.

Sponsors & Collaborators

  • Hemab ApS

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-06
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • Australia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06754852 on ClinicalTrials.gov