Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06754852
PHASE1/PHASE2

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

Sponsor: Hemab ApS

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-002 in Participants With Von Willebrand Disease (Velora Pioneer)

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2025-02-06

Completion Date

2027-07

Last Updated

2025-12-09

Healthy Volunteers

No

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.

Locations (4)

Fiona Stanley Hospital

Murdoch, Perth, Australia

Royal Prince Alfred Hospital

Camperdown, Sydney, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Richmond Pharmacology

London, United Kingdom