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A study to compare the safety of ketamine hydrochloride and esketamine in healthy men for the treatment of depression

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What is this trial about?

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

This study aims to compare how two different medications work in the body for the treatment of Depression. One medication is esketamine, which is given as a nasal spray. The other medication being studied is known as KET01, which is a ketamine hydrochloride prolonged release tablet, meaning the medicine is released slowly into the body over time after being swallowed.

Participants will take part in a process where they receive different treatments at different times. During the study, some individuals will receive the active medications, while others will receive a placebo. The research focuses on how well these substances are tolerated and how they move through the body, specifically looking at dissociative symptoms, which are feelings of being disconnected from one's body or surroundings.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>period 1</b>

    During the first period, a single dose of either ketamine hydrochloride prolonged release tablets at 240 mg or esketamine nasal spray at 84 mg is administered.

    It is not known if the medication received is the active medicine or a placebo, which is an inactive substance used for comparison.

  2. Step 2

    <b>washout period</b>

    A period of time occurs where no study medication is taken to ensure the first dose is completely out of the body.

  3. Step 3

    <b>period 2</b>

    During the second period, the other medication is received. if the first period involved the ketamine hydrochloride tablets, the second period will involve the esketamine nasal spray, or vice versa.

    The dose remains 240 mg for the tablets or 84 mg for the nasal spray.

Who can join the trial?

5 criteria

  • You must be a male.
  • You must be at least 18 years old but no older than 45 years old when you sign the agreement to join the study.
  • You must be considered healthy after a full medical check-up, which includes a detailed review of your past medical history (your record of past illnesses and health issues).
  • Your Body Mass Index (a measurement used to see if your weight is healthy for your height) must be between 18.5 and 30.
  • You must weigh at least 50 kg (about 110 pounds).

Who cannot join the trial?

12 criteria

  • You cannot participate if you have any physical issues or medical conditions that might stop the study medicine from entering your body or working correctly, such as having had facial reconstruction (surgery to rebuild the face), rhinoplasty (nose reshaping surgery), or any major problems with the structure or function of your nose or airway, including nasal piercings.
  • You are excluded if you have obstructions (blockages) or mucosal lesions (sores or growths on the lining of the nose) in your nostrils or nasal passages.
  • You cannot join if you have had sinus surgery (surgery on the cavities in your skull around your nose) within the last 2 years.
  • You are ineligible if you show signs of rhinitis (inflammation or swelling of the inside of the nose, often causing sneezing or a runny nose) on the days you are meant to take the study medicine.
  • You cannot participate if you have any history of surgery that the doctor believes might affect how the medicine is absorbed into your system.
  • You are excluded if you have ever used ketamine, esketamine (including during medical anesthesia), or other dissociative drugs (medicines that can make you feel detached from your body or surroundings), such as PCP, Nitrous Oxide, or high doses of dextromethorphan (a common cough medicine).
  • You cannot join if you have any significant medical conditions affecting your cardiovascular (heart and blood vessels), pulmonary (lungs), gastrointestinal (stomach and intestines), hepatic (liver), renal (kidneys), hematological (blood), psychiatric (mental health), neurological (brain and nervous system), musculoskeletal (muscles and bones), endocrine (hormones), metabolic (how the body uses energy), or malignant (cancerous) systems, if the doctor believes these could put you at risk or change the study results.
  • You are excluded if your first-degree relatives (your parents, brothers, sisters, or children) have psychotic disorders (severe mental conditions involving loss of contact with reality) or bipolar disorders (conditions involving extreme mood swings).
  • You cannot participate if there is a family history of sudden cardiac death (unexpected death caused by heart failure) in your immediate family members.
  • You are ineligible if you have a history of alcohol use disorder or substance use disorder (addiction or problematic use of drugs), including benzodiazepines (anti-anxiety medications), opiates (strong pain relievers), hallucinogens (drugs that cause hallucinations), stimulants (drugs that increase body activity, like cocaine or amphetamines), or cannabis, unless it is just nicotine or caffeine.
  • You cannot join if you have a positive drug abuse test.
  • You are excluded if you have hypertension (high blood pressure), defined as a systolic (top number) reading of 140 mmHg or higher, or a diastolic (bottom number) reading of 90 mmHg or higher after resting for 5 minutes.
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Investigated drugs

  • Esketamine

    is a medication administered as a nasal spray that is used in this study to compare its effects and safety against an oral medication.

  • Ketamine

    is a medication provided in the form of tablets that are designed to release into the body slowly over time, and it is being tested to see how well it is tolerated when taken orally.

What is already known about the treatment

  • Esketamine hydrochloride

    This medication is administered as a liquid solution through a nasal spray applied into the nostrils. It is currently an approved treatment used primarily to help manage depression in adults. The drug works by blocking specific receptors in the brain called NMDA receptors, which helps to balance chemical signals that regulate mood. It is classified as an NMDA receptor antagonist.

  • Ketamine hydrochloride

    This medication is taken orally in the form of tablets designed to release the medicine slowly into the body over time. While widely studied in medical literature for various uses, it is often investigated for its potential to treat depression. It works at a molecular level by interfering with certain communication pathways in the brain, specifically by acting on NMDA receptors to change how brain cells connect. It is classified as an NMDA receptor antagonist.

Investigated diseases

Depression - This condition is a mood disorder that causes a persistent feeling of sadness and a loss of interest in activities once enjoyed. It can affect how a person feels, thinks, and handles daily activities such as sleeping, eating, or working. The symptoms may develop gradually or appear suddenly following a stressful event. Over time, the emotional state can become increasingly heavy and difficult to manage. It often involves changes in brain chemistry that affect mood regulation.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503971-45-00Protocol codeKET01-03Estimated enrolment26 patientsSponsorKetabon GmbH

sourced from the EU Clinical Trials Register and site verification

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