Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06754852 | A Study Assessing HMB-002 in Participants With Von Willebrand Disease | PHASE1 | RECRUITING | 108 | — | — | Feb 6, 2025 | Jul 1, 2027 | Dec 9, 2025 | 4 | Australia, United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Part A Single Ascending Dose Design | EXPERIMENTAL | A multicenter study to evaluate the safety, tolerability, PK, and PD effect of single dose HMB-002 in participants with Type 1 VWD. |
| Part B Multiple Dose Assessment | EXPERIMENTAL | A multicenter study to evaluate the safety, tolerability, PK, and PD effect of 3 repeat doses of HMB-002, as well as the preliminary prophylactic effects on bleeding events. |
| Name | Type | Description |
|---|---|---|
| HMB-002 (Part A) | DRUG | 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. |
| HMB-002 (Part B) | DRUG | 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. |
Inclusion Criteria: 1. Has the ability to provide informed consent to participate in the study, in accordance with applicable regulations. 2. Has an understanding, ability, and willingness to comply with study procedures and restrictions. 3. ≥18 and \<65 years. 4. Weight 50 to 110 kg, inclusive. 5....