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Phase 1 Safety and Tolerability of Oral VENT-02 in Healthy Volunteers for Neuroinflammatory and Neurodegenerative Diseases

Investigational
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on conditions that affect the brain’s immune system and lead to progressive loss of nerve cells, referred to as neuroinflammatory and neurodegenerative diseases. The investigational medicine being tested is a pill called VENT-02, which is taken by mouth in a hard‑capsule form. A matching inactive pill, known as placebo, is also used for comparison.

The main goal of the trial is to evaluate the safety and tolerability of the drug when given in single and multiple increasing doses. Researchers will also examine how the body processes the medication (pharmacokinetics) and how the medication influences the body (pharmacodynamics). Participants will receive a single dose, followed by a series of daily doses that become higher over time. Throughout the study, volunteers will undergo routine check‑ups that include blood and urine tests, measurements of vital signs, a heart rhythm test called an ECG, a continuous heart monitoring test called a Holter ECG, and a physical examination. Any unwanted effects, referred to as adverse events, will be recorded and reviewed.

The trial is conducted in healthy adult volunteers who will attend several visits over a period of several weeks. At each visit, the scheduled assessments are performed, and the dose may be adjusted according to the study plan. The overall timeframe allows researchers to collect information on how the drug behaves in the body and whether it is well‑tolerated before it can be studied in patients with the targeted brain disorders.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessments and Randomization

    After joining the study, you will undergo initial health checks that include blood tests, urine analysis, measurement of vital signs such as blood pressure and heart rate, and an electrocardiogram (ECG) to record the electrical activity of the heart.

    Based on these results, you will be randomly assigned to receive either VENT-02 or a matching placebo without knowing which one you receive.

  2. Step 2

    Single Dose Administration

    If you are assigned to the active group, you will take one oral hard capsule containing 1800 mg of vent-02. The capsule is swallowed with water.

    If you are assigned to the placebo group, you will take an identical capsule that does not contain the active substance.

  3. Step 3

    Safety Monitoring After Single Dose

    Following the dose, you will remain in the clinic for several hours while staff observe you for any treatment‑emergent (serious) adverse events, such as unexpected symptoms or reactions.

    Additional checks will include repeat blood and urine tests, vital‑sign measurements, and another ECG to ensure your heart rhythm remains normal.

  4. Step 4

    Multiple Dose Administration (If Assigned to Active Group)

    Participants who continue in the multiple‑dose part of the study will take one 1800 mg oral capsule of vent-02 each day for the duration specified by the study protocol.

    Placebo participants will take a matching capsule on the same schedule.

  5. Step 5

    Ongoing Monitoring and Final Evaluation

    During the multiple‑dose period, you will have regular visits for safety checks that include blood and urine laboratory tests, vital‑sign measurements, ECG recordings, and a physical examination.

    At the end of the study, a final assessment will be performed to collect all safety data and to evaluate any changes in the measured parameters.

Who can join the trial?

5 criteria

  • Provide a signed informed consent form and be willing and able to follow the study rules.
  • Be a healthy man or woman: ages 18‑55 for parts A and C, or ages 45‑65 for part B. Health is confirmed by a medical history, a full physical exam, checking vital signs (such as blood pressure and heart rate), laboratory tests, and a 12‑lead ECG (a test that records the heart’s electrical activity). No serious ongoing or uncontrolled chronic disease (long‑lasting conditions like heart or lung disease) should be present.
  • Agree to use effective contraception (birth control) during the study if you are male or a woman who could become pregnant, and continue using it for up to 90 days after the last dose.
  • Have a body mass index (BMI) between 18 and 32 kg/m² and weigh at least 50 kg. BMI is a measure that compares weight to height to assess if weight is in a healthy range.
  • Be able to communicate well with the Investigator in Dutch and be willing to follow any study restrictions.

Who cannot join the trial?

6 criteria

  • If you have any current serious illness—whether a sudden, short‑term acute condition or a long‑lasting chronic disease—that could affect the study or make the medicine unsafe for you, you cannot join.
  • If you have a past or ongoing major health problem that is not well‑controlled, such as blood‑related (hematological), kidney (renal), hormone (endocrine), stomach/intestine (gastrointestinal), liver (hepatic), heart or blood‑vessel (cardiovascular), lung (pulmonary), skin (dermatological), or brain/nervous‑system (neurological) disorders, you cannot join.
  • If you have ever had a seizure (except a fever‑related seizure in early childhood) or have a brain condition that could increase seizure risk—such as a serious head injury (traumatic brain injury), stroke, brain tumor (intracranial mass lesion), brain infection (neuro‑infection), or developmental brain disorder—you cannot join.
  • If you have a disease that weakens your immune system (immune system impairment), such as an auto‑immune disease (where the body attacks itself), HIV infection, missing or non‑functioning spleen (asplenia), or frequent severe infections, you cannot join.
  • If you have a significant infection—viral, bacterial, fungal, or tuberculosis‑type (mycobacterial)—within the past 30 days that required medical treatment (excluding simple nail fungus onychomycosis), you cannot join.
  • If you have taken part in another clinical study of drugs that block NLRP3 (a specific inflammation pathway) in the last 2 years, you cannot join.
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Investigated drugs

VENT-02 is an experimental oral medication that comes in hard‑capsule form. In this study, volunteers swallow the capsule to see how the drug is absorbed, how it behaves in the body, and whether it is safe and well‑tolerated. The trial gives the capsules at increasing amounts to healthy participants so researchers can learn about any side effects and how the body processes the drug. This information helps determine if VENT-02 can be studied further for treating disease.

What is already known about the treatment

VENT-02 - VENT-02 is taken by mouth as a hard capsule containing 1800 mg of the drug. It is an experimental medicine that is still in early clinical trials and has not yet been approved for any medical use. The capsule is being studied for diseases that involve brain inflammation and nerve cell loss, such as certain neurodegenerative conditions. It works by blocking specific signals that cause inflammation in brain cells and is classified as an investigational anti‑inflammatory agent.

Investigated diseases

Neuroinflammatory and neurodegenerative diseases - These conditions involve abnormal inflammation within the brain or spinal cord, which can damage nerve cells. Over time, the inflammation often leads to a gradual loss of neurons and their connections. This loss results in worsening symptoms such as memory problems, movement difficulties, or sensory changes. The disease process typically starts subtly and becomes more pronounced as more nerve tissue is affected. Ongoing damage can spread to different parts of the nervous system, increasing functional impairment.
Trial detailsLast updated 20 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505546-26-00Estimated enrolment86 patientsSponsorVentus Therapeutics U.S. Inc.

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