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NCT06754852 · ClinicalTrials.gov registry record · Phase 1
A Study Assessing HMB-002 in Participants With Von Willebrand Disease
A Phase 1 study, sponsored by Hemab ApS.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
NCT06754852 is a Phase 1 study that is actively recruiting participants, run by Hemab ApS. The registered enrollment target is 108 participants.
The verdict
NCT06754852, a Phase 1 study, is actively recruiting participants, sponsored by Hemab ApS.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
Study Summary
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 dosing will be established prior to cohort expansion to explore efficacy. Part C will evaluate the safety, PK, and PD of a single concomitant dose of HMB-002 and factor concentrate with Type 3 VWD or Type 1 VWD with low residual VWF and FVIII who use factor concentrate as prophylaxis.
Interventions
- DRUG HMB-002 (Part A)
- DRUG HMB-002 (Part B)
- DRUG HMB-002 with Concomitant Factor Concentrate (Part C) (Not Applicable in US)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2025-02-06 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06754852
The ClinicalTrials.gov registry entry for NCT06754852 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hemab ApS, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which HMB-002 (Part A) is the first listed.
NCT06754852 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06754852 about?
NCT06754852 is a clinical study titled "A Study Assessing HMB-002 in Participants With Von Willebrand Disease". 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 safe...
What is the current status of trial NCT06754852?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2025-02-06. Estimated completion is 2027-07.
What interventions are being tested in trial NCT06754852?
The interventions under investigation include: HMB-002 (Part A) (DRUG), HMB-002 (Part B) (DRUG), HMB-002 with Concomitant Factor Concentrate (Part C) (Not Applicable in US) (DRUG).
Who is sponsoring clinical trial NCT06754852?
This trial is sponsored by Hemab ApS, which has 3 total clinical trials registered on ClinicalTrials.gov.
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