drugset / Trial / NCT01486628
Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
RandomizedParallel-groupTriple-blindTreatment
Summary
It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in healthy volunteers. Objectives are to determine: 1. the maximal tolerated dose of SC ND-0612 2. the steady state plasma concentration of LD and CD following SC ND-0612 administration. Each treatment group will include 6 healthy volunteers. Dosing will be done in a sequential manner.
Timeline
- Start
- 2012-04-30
- Primary completion
- 2012-11-22
- Completion
- 2013-06-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carbidopa | Unknown | — | Subcutaneous |
| Comparator | Levodopa | Small molecule | — | Subcutaneous |