Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VV-14305 · 1 trial · 1 indication
Incidence and severity of ocular and non-ocular adverse events, clinical laboratory values, physical examinations, vital signs, and ophthalmic examinations
Incidence and severity of ocular and non-ocular adverse events, clinical laboratory values, physical examinations, vital signs, and ophthalmic examinations
Percentage of participants with reduction in proptosis in the study eye as measured by exophthalmometer
| Arm | Type | Description |
|---|---|---|
| Part 1 Cohort 1, dose #1 | EXPERIMENTAL | A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. |
| Part 1 Cohort 2, dose #2 | EXPERIMENTAL | A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. |
| Part 1 Cohort 3, dose #3 | EXPERIMENTAL | A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. |
| Part 1 Cohort 4, dose #4 | EXPERIMENTAL | A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. |
| Part 1 Cohort 5, dose #5 | EXPERIMENTAL | A single dose of VV-14305 will be administered. In addition, prednisone will be administered prior to and after VV-14305. |
| Part 1 Optional Cohort 6, Part 2 dose | EXPERIMENTAL | A single dose of VV-14305 determined from Cohorts 1 to 5 will be administered. In addition, prednisone will be administered prior to and after VV-14305. |
| Part 2 Treatment Arm | EXPERIMENTAL | A single dose of VV-14305 determined from Cohorts 1 to 5 will be administered. In addition, prednisone will be administered prior to and after VV-14305. |
| Part 2 Sham Arm | EXPERIMENTAL | A single sham injection will be administered. In addition, prednisone will be administered prior to and after the sham injection |
| Name | Type | Description |
|---|---|---|
| VV-14305 | GENETIC | VV-14305 will be administered via peribulbar injection. |
| Sham (No Treatment) | OTHER | Sham solution such as Saline |
Inclusion Criteria: 1. Must be 18 to 80 years of age (inclusive) at Screening. 2. Must be euthyroid (defined as normal thyroid-stimulating hormone) or have mild hyper- or hypothyroidism (being managed to bring them to a euthyroid state). 3. Best Corrected Visual Acuity (BCVA) score of 20/60 or bett...