NCT01486628

Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: NeuroDerm Ltd. · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	ND0612	levodopa and carbidopa solution for subcutaneous administration
DRUG	Placebo	Saline solution for SC continuous administration

Timeline

• Start date: 2012-04-30
• Primary completion: 2012-11-22
• Completion: 2013-06-13
• First posted: 2011-12-06
• Last updated: 2024-01-18

Locations

1 site across 1 country: Israel