Can a pill deliver Ketamine's benefits without the risks?
NCT ID NCT07791303
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
Researchers are testing an oral drug called Ketamir-2, a chemical cousin of ketamine, in healthy adults aged 18 to 65. The trial gives single or repeated doses to small groups and compares them against a placebo to see how the body handles the drug and what side effects occur. The goal is to find a safe dose and understand how Ketamir-2 is absorbed and cleared, which could support future studies for conditions like depression or pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ketamir-2 (also called Ketamir hemipamoate), an oral capsule form of a ketamine-related compound
- What this could lead to
- If it works, this could point toward a safer, oral alternative to ketamine for conditions like depression or chronic pain.
- What could go wrong
- This is an early phase 1 trial in healthy volunteers, so it only tests safety and dosing, not effectiveness. The drug may cause side effects similar to ketamine, such as psychedelic effects or changes in blood pressure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
57 people
The number who actually took part.
- Started
-
Mar 2025
- Finished
-
Mar 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female participants, ages 18-65. 2. Understands the study procedures described in the Informed Consent Form, be willing and able to comply with the protocol, and provides written consent. 3. Not pregnant or lactating and willing to comply with the contraceptive requirements from enrollment to 3 months post last dose. 4. In good health with no history of clinically significant medical conditions or suicide liability that would interfere with participant safety, as defined by medical history, physical examination and routine laboratory tests, ECG and determined by the Investigator at an admission evaluation. 5. Participants will have a documented medical history either prior to entering the study and/or following medical history review with the study physician at screening. Exclusion Criteria: 1. History or evidence of any clinically significant or currently active cardiovascular, (including thromboembolic events), respiratory, dermatological, gastrointestinal, endocrine, hematological, hepatic, immunological, rheumatological, metabolic, urological, renal, neurological, psychiatric illness. 2. History of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the principal investigator (PI). 3. History or presence of alcohol addiction, or excessive use of alcohol, or use of drugs of abuse. 4. Psychiatric illness including participants with a history of depression and/or anxiety with associated severe psychiatric comorbidities, for example psychosis. 5. Participants who are currently smoking or former regular cigarette smokers. 6. Body Mass Index (BMI) ≤18 Kg/m2 and ≥28 Kg/m2. 7. Venous access is deemed inadequate for the phlebotomy and cannulation demands of the study. 8. At the discretion of the PI, any clinically significant abnormal finding on screening biochemistry, hematology, serology microbiology blood tests or urinalysis or positive HIV, active/chronic hepatitis B or C test. 9. Twelve-lead ECG recording with clinically relevant abnormalities as judged by the study physician/PI. 10. Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to screening. 11. Use of any medication or product (prescription or over the counter), including therapeutics for central nervous system activity (such as Ritalin, and its derivatives, antidepressants, hypnotics, anti-psychotics, or similar) within 14 days or 5 half-lives (whatever is longer) prior to screening until completion of the study. 12. Receipt of any investigational drug within 3 months prior to screening or receipt of three or more investigational drugs within the previous 12 months prior to screening. 13. Over the counter medications (e.g., paracetamol or ibuprofen) where the dose taken over the preceding 14 days prior to the planned date of drug administration had exceeded the maximum permissible 24-hour dose. 14. Participants who have received any systemic chemotherapy agent, immunoglobulins, or other cytotoxic or immunosuppressive drugs at any time.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hadassah Clinical Research Unit
Jerusalem, Israel
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Other studies related to the condition(s) this trial covers.
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