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

January 17, 2024 updated by: NeuroDerm Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: levodopa and carbidopa
Drug: ND0612
levodopa and carbidopa solution for subcutaneous administration
Placebo Comparator: Placebo
Saline solution for subcutaneous administration
Drug: Placebo
Saline solution for SC continuous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: 2 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroDerm Ltd.

Investigators

  • Principal Investigator: Yoseph Caraco, MD, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2012

Primary Completion (Actual)

November 22, 2012

Study Completion (Actual)

June 13, 2013

Study Registration Dates

First Submitted

December 4, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (Estimated)

December 6, 2011

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ND0612/001 and 001b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on ND0612

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe