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Ketamir-2 · 1 trial · 1 indication
Clinical laboratory assessments include urinalysis and blood tests. Clinically significant laboratory abnormality is determined by the investigator.
Vital sign assessments include blood pressure, heart rate, respiratory rate, and oral temperature. Clinically significant vital sign abnormality is determined by the investigator.
Safety ECG will be assessed using 12-lead ECG recordings. Clinically significant abnormality is determined by the investigator.
A focused physical examination will be performed prior to dosing on Day 1 and upon discharge on Day 2. For cohorts 5-7, a focused physical examination will be performed prior to dosing on Day 1, on Day 3, and Day 6. Examination of the cardiovascular system is mandatory, while the other body systems will be examined at the discretion of the Principal Investigator.
The Ketamine Side Effect Tool will be used to assess ketamine-related side effects.
The Bowdle VAS is a tool used to measure the psychedelic effects of substances. It consists of 13 items (each scored on 0-100 mm) that assess both internal perception and external perception. Higher scores indicate greater subjective effects.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Single Dose Ketamir-2 50 mg or Placebo | EXPERIMENTAL | Participants in Cohort 1 were randomized in a 3:1 ratio to receive a single oral dose of Ketamir-2 50 mg or matching placebo on Day 1. Ketamir-2 was administered as one 50 mg capsule. Matching placebo was administered as one capsule. |
| Cohort 2: Single Dose Ketamir-2 150 mg or Placebo | EXPERIMENTAL | Participants in Cohort 2 were randomized in a 3:1 ratio to receive a single oral dose of Ketamir-2 150 mg or matching placebo on Day 1. Ketamir-2 was administered as three 50 mg capsules. Matching placebo was administered as three capsules. |
| Cohort 3: Single Dose Ketamir-2 300 mg or Placebo | EXPERIMENTAL | Participants in Cohort 3 were randomized in a 3:1 ratio to receive a single oral dose of Ketamir-2 300 mg or matching placebo on Day 1. Ketamir-2 was administered as one 300 mg capsule. Matching placebo was administered as one capsule. |
| Cohort 4: Single Dose Ketamir-2 600 mg or Placebo | EXPERIMENTAL | Participants in Cohort 4 were randomized in a 3:1 ratio to receive a single oral dose of Ketamir-2 600 mg or matching placebo on Day 1. Ketamir-2 was administered as two 300 mg capsules. Matching placebo was administered as two capsules. |
| Cohort 5: Ketamir-2 150 mg Once Daily for 5 Days or Placebo | EXPERIMENTAL | Participants in Cohort 5 were randomized in a 3:1 ratio to receive Ketamir-2 150 mg or matching placebo once daily for 5 days, from Day 1 through Day 5. Ketamir-2 was administered as three 50 mg capsules once daily. Matching placebo was administered as three capsules once daily. |
| Cohort 6: Ketamir-2 300 mg Once Daily for 5 Days or Placebo | EXPERIMENTAL | Participants in Cohort 6 were randomized in a 3:1 ratio to receive Ketamir-2 300 mg or matching placebo once daily for 5 days, from Day 1 through Day 5. Ketamir-2 was administered as one 300 mg capsule once daily. Matching placebo was administered as one capsule once daily. |
| Cohort 7: Ketamir-2 600 mg Once Daily for 5 Days or Placebo | EXPERIMENTAL | Participants in Cohort 7 were randomized in a 3:1 ratio to receive Ketamir-2 600 mg or matching placebo once daily for 5 days, from Day 1 through Day 5. Ketamir-2 was administered as two 300 mg capsules once daily. Matching placebo was administered as two capsules once daily. |
| Name | Type | Description |
|---|---|---|
| Ketamir-2 | DRUG | Ketamir-2, also referred to as Ketamir hemipamoate, was administered orally as capsules containing 50 mg or 300 mg. Participants randomized to active treatment received Ketamir-2 according to assigned dose cohort. Cohorts 1 through 4 received a single dose on Day 1. Cohorts 5 through 7 received once-daily dosing from Day 1 through Day 5. Capsules were swallowed together with a glass of water after an overnight fast. |
| Placebo | DRUG | Placebo capsules were identical in appearance to active capsules and were administered orally according to the same number of capsules and dosing schedule as the corresponding Ketamir-2 dose cohort. |
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 requi...
Ketamir-2 is an investigational small molecule being developed by MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA). It is currently in Phase 1 clinical development. A completed Phase 1 trial studied its safety, tolerability, and pharmacokinetics after oral administration in healthy adult participants.
Ketamir-2 is being studied for use in healthy adult participants. The completed Phase 1 clinical trial evaluated its safety, tolerability, and pharmacokinetics in this population. It is an investigational drug and has not been approved for any medical condition.
Ketamir-2 is being developed by MIRA Pharmaceuticals, Inc., a company traded on NASDAQ under the ticker symbol MIRA. The company is conducting clinical research on this investigational small molecule.
Ketamir-2 is in Phase 1 clinical development. A Phase 1 trial, NCT07791303, has been completed. This trial enrolled 57 healthy adult participants in Israel. Ketamir-2 is investigational and has not been approved by regulatory authorities.
Ketamir-2 has one completed clinical trial, NCT07791303, titled "Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects." This Phase 1 study enrolled 57 healthy adult participants in Israel and was double-blind and controlled.
Ketamir-2 is a distinct investigational small molecule developed by MIRA Pharmaceuticals, Inc. It is not the same as ketamine. While its name is similar, Ketamir-2 is a separate compound being studied in early clinical trials for its safety and pharmacokinetic profile.