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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: ND0612
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Caucasian males between 18 and 40 years (inclusive) of age Normal BMI (18.5-24.9) Subjects with negative urinary drugs of abuse, HIV, Hepatitis B or Hepatitis C serology tests Subjects must be able to adhere to the protocol requirements Subjects must provide written informed consent to participate in the study. Exclusion Criteria: History of significant psychiatric disorder, neurological diseases or sleep disorders History of significant systemic diseases, by medical history or tests performed during screening examinations Clinically significant laboratory tests at screening History of drug or alcohol abuse. Allergy to levodopa, carbidopa or any inactive component of the test formulation. Subjects with dark skin Subjects with skin diseases or neoplasms Subjects with narrow-angle glaucoma Subjects with significant allergic response to other drugs. Presence of clinically significant scars or other skin disorders in the area of placement of the pump. Use of any prescription or over-the-counter (OTC) medications Subjects who donated blood or received blood, in the last 3 months Participation in another clinical trial in the last 30 days Subjects which do not have the ability to communicate well or will not adhere to the protocol procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: levodopa and carbidopa<br> | Drug: ND0612<br>* levodopa and carbidopa solution for subcutaneous administration<br>|
| Placebo Comparator: Placebo<br>Saline solution for subcutaneous administration | Drug: Placebo<br>* Saline solution for SC continuous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | 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 | 2 weeks |