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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
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.
Age
18 - 40 years
Sex
MALE
Healthy Volunteers
Yes
Hadassah Medical Center
Jerusalem, Israel
Start Date
April 30, 2012
Primary Completion Date
November 22, 2012
Completion Date
June 13, 2013
Last Updated
January 18, 2024
36
ACTUAL participants
ND0612
DRUG
Placebo
DRUG
Lead Sponsor
NeuroDerm Ltd.
NCT07310264
NCT02119611
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07216976