Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
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:
- the maximal tolerated dose of SC ND-0612
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers|
- Safety and tolerability [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
The safety and tolerability of ND0612 will be well monitored and will assess the ND0612 effect at various doses in comparison to placebo in the following parameters:
- Incidence and frequency of local adverse events related to the ND0612 Sc administration.
- Local safety scoring. In addition, systemic adverse events and withdrawal rates and discontinuations due to adverse events will be recorded
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Placebo Comparator: levodopa and carbidopa||
levodopa and carbidopa solution for subcutaneous administration
Placebo Comparator: Placebo
Saline solution for subcutaneous administration
Saline solution for SC continuous administration
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486628
|Hadassah Medical Center|
|Principal Investigator:||Yoseph Caraco, MD||Hadassah Medical Center, Israel|