A Study Assessing HMB-002 in Participants With Von Willebrand Disease
Recruiting
Phase 1
Phase 2
Interventional Study
Von Willebrand Disease (VWD)
Von Willebrand Disease (VWD), Type 1
Von Willebrand Disease (VWD), Type 2
Von Willebrand Disease (VWD), Type 3
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 – 69
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 108 (estimated)
- Sponsor
- Hemab ApS · Industry
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About This Trial
This is a first-in-human (FIH), Phase 1/2, 3-part open-label, dose escalation, safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and efficacy study evaluating HMB-002 in participants with VWD. Part A of the study involves a single ascending dose (SAD) regimen design to establish safety, tolerability, PK, and PD effect. In Part B of the study, the safety and tolerability of repeat d…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
1. Weight 50 to 120 kg, inclusive.
2. Documented diagnosis of Congenital VWD, confirmed by laboratory testing consistent with ISTH/ASH) diagnostic guidelines).
3. Vital signs are within normal ranges at Screening.
4. Participants must meet the following baseline organ functi…
Contacts