In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.
Design: single center, double-blind, randomized, placebo-controlled, crossover study. Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments. Population: Eight (8) PD subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
Hadassah Medical Center
Jerusalem, Israel
Incidence and frequency of adverse events
1. Incidence and frequency of adverse events 2. Adverse events reporting related to the ND0612 application, local safety score
Time frame: up to 8 weeks
Withdrawal rate
Withdrawal rates and discontinuations due to adverse events
Time frame: 2 days
LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC
LD PK profile after oral LD dosing administered with or without ND0612:
Time frame: Up to 2 days
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