Can a pill deliver Ketamine's benefits without the risks?

NCT ID NCT07791303

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Healthy adult participants are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.