drugset / Trial / NCT03307837
A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity
RandomizedSequentialDouble-blindTreatment
Summary
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo.
Timeline
- Start
- 2017-11-02
- Primary completion
- 2018-03-20
- Completion
- 2018-04-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | vocacapsaicin | Small molecule | 0.5 mg | Other |
| Comparator | vocacapsaicin | Small molecule | 1 mg | Other |
| Comparator | vocacapsaicin | Small molecule | 2 mg | Other |
| Comparator | vocacapsaicin | Small molecule | 3 mg | Other |
| Comparator | vocacapsaicin | Small molecule | 4.2 mg | Other |
Indications
No indication recorded.