drugset / Trial / NCT03197623
Safety and Tolerability of Intravenous LLP2A-Alendronate for Osteopenia Secondary to Glucocorticoids
Phase 1
Completed
58 enrolled
Nancy E. Lane, MD
California Institute for Regenerative Medicine (CIRM) · collab
RandomizedSequentialTriple-blindTreatment
Summary
A Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women with Osteopenia Secondary to Corticosteroids
Timeline
- Start
- 2016-10-14
- Primary completion
- 2021-03-15
- Completion
- 2021-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LLP2A-ALENDRONATE | Small molecule | 50 ug/kg | Intravenous |
| Subject | LLP2A-ALENDRONATE | Small molecule | 150 ug/kg | Intravenous |
| Subject | LLP2A-ALENDRONATE | Small molecule | 400 ug/kg | Intravenous |
| Subject | LLP2A-ALENDRONATE | Small molecule | 750 ug/kg | Intravenous |
| Subject | LLP2A-ALENDRONATE | Small molecule | 1200 ug/kg | Intravenous |