Safety and Tolerability of NT-0796, Nadroparin, and Lidocaine Hydrochloride in Healthy Volunteers and Patients with Parkinson’s Disease

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What is this study about?

The trial examines people with Parkinson’s Disease, a brain condition that leads to shaking, stiffness and slowed movements, and evaluates the oral capsule called NT-0796. During the study, occasional use of lidocaine hydrochloride – an injection that temporarily numbs the area – and nadroparin calcium – an injection that helps prevent blood clots – may be required for certain procedures. The purpose of the research is to determine whether NT-0796 is safe and well tolerated.

Participants will take the study medication and attend a few scheduled visits where simple blood draws and other routine tests are performed to assess the drug’s pharmacokinetics (how the body absorbs and clears the medication) and pharmacodynamics (how the medication affects the body). Researchers will record any side effects, known as adverse events, and any changes in standard blood test results. The overall study period is short, with regular monitoring to ensure participant safety.

1 enrollment and screening

after signing the informed consent form, you will undergo screening procedures that include a review of your medical history, a physical examination, and laboratory tests to confirm eligibility for the study.

2 baseline visit

on the first study day, baseline measurements such as vital signs, neurological assessment for parkinson’s disease, and additional laboratory samples will be collected before any medication is given.

3 administration of study drug nt-0796

you will receive one oral capsule of nt-0796 containing 300 mg. the capsule is taken by mouth as instructed by the study staff.

4 administration of background medications

as part of the study protocol, you may receive an injection of lidocaine hydrochloride solution (10 mg per ml) and an injection of nadroparin calcium (1 IU). these injections are given according to the schedule defined by the investigators.

5 monitoring and safety assessments

throughout the study period, you will attend regular visits where vital signs, neurological status, and any side effects will be recorded.

repeated laboratory tests will be performed to monitor safety and to detect any changes in clinical values.

6 final assessment and study completion

at the end of the study, a final set of evaluations similar to the baseline visit will be performed.

study medication will be discontinued, and you will receive a summary of the study results that relate to safety and tolerability.

Who Can Join the Study?

Sign the informed consent form and be willing to follow the study’s instructions.
Be between 18 and 75 years old at the time of screening.
Agree to have spinal fluid taken through a lumbar puncture (a short needle placed in the lower back to collect fluid).
If you are a woman who could become pregnant (women of child‑bearing potential), you must either avoid sex or use a very reliable form of contraception, and you cannot donate eggs, from 28 days before the first dose until 90 days after the last dose.
If you are a man, you must use a condom (called barrier protection) when having sex with a woman who could become pregnant during the study and for 90 days after the last dose, and you should ask your partner to use an effective birth‑control method if she could become pregnant, is pregnant, or is nursing.

Who Cannot Join the Study?

Pregnant or breastfeeding women cannot join the study; this means anyone who knows they are pregnant, has a positive pregnancy test, or is feeding a baby with breast milk.
Problems with the immune system exclude a person; this includes diseases that weaken the body’s defenses such as autoimmune diseases (where the body attacks itself), HIV (a virus that damages immune cells), asplenia (missing or non‑functioning spleen), repeated serious infections, or taking medicines that suppress the immune system for more than 14 days in the past 6 months (or any single use in the past 30 days).
Severe drug allergies prevent participation; this covers any confirmed allergic reaction to medications, including skin rashes or anaphylaxis (a rapid, life‑threatening allergic reaction), as well as other significant allergies.
Psychiatric or cognitive issues that could interfere with the study or following instructions also exclude a person; examples are mental health conditions or problems with thinking, memory, or understanding that might affect participation.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Qwp Nqqghybtlow Bwtc	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	04.04.2023

Trial locations

Investigated Drugs:

NT-0796 is an experimental oral capsule being studied for the first time in people who are healthy and in patients with Parkinson’s disease. The trial is looking at how safe it is, how well people can tolerate it, and how the drug moves through the body and affects the disease. Participants take the capsule by mouth during the study.

Lidocaine is a medication given by injection that numbs a small area of the body. In this trial it is used to provide local anesthesia during any minor procedures or blood draws, making the process more comfortable for the participants.

Nadroparin is an injection that works as an anticoagulant, which means it helps prevent blood clots. It is given to participants as a precaution to reduce the risk of clotting while they are part of the study.

Parkinson’s disease – Parkinson’s disease is a brain disorder that slowly damages nerve cells that control movement. It usually begins with a slight tremor in one hand, stiffness, or slower movements. Over time the tremor can appear on both sides of the body and walking may become difficult. Muscle stiffness may increase, making everyday tasks harder. Non‑motor changes such as sleep problems, mood changes, or reduced sense of smell can also develop as the condition advances.

Trial ID:

2023-503203-29-00

Protocol code:

NT-0796-P002

Trial Phase:

Human Pharmacology (Phase I) – Other

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Safety and Tolerability of NT-0796, Nadroparin, and Lidocaine Hydrochloride in Healthy Volunteers and Patients with Parkinson’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?