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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06980649 | Study of BHV-1300 in Graves' Disease | PHASE1 | RECRUITING | 15 | — | — | Aug 21, 2025 | Sep 1, 2027 | May 22, 2026 | 17 | United States, Australia |
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation or deaths that are observed during the Open-label Treatment Phase (up to 52 weeks).
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.
| Arm | Type | Description |
|---|---|---|
| BHV-1300 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BHV-1300 | DRUG | BHV-1300 is delivered subcutaneously (SC) |
Key Inclusion Criteria: 1\. Participants must have serologically confirmed Graves' Disease. Key Exclusion Criteria: 1. History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within six weeks of the Baseline visit...