Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects
← catalyst calendarSponsored by MIRA Pharmaceuticals (industry) · MIRA — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Na · Quadruple · Treatment
Enrollment
57actual
Sites
1
Country
Israel
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-27
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-03-20 | actual | When the study began enrolling |
| Primary completion | 2026-03-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-03-05 | actual | The whole study's end, after follow-up |
| First posted | 2026-08-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Adult Participants
Interventions
- Drug: Ketamir-2
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Incidence of adverse events
measured From first dose through dosing period until 7 days post last dose
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
measured From baseline through end of study visit
Number of Participants With Clinically Significant Vital Sign Abnormalities
measured From baseline through end of study visit
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities on a 12-Lead ECG
measured From baseline through end of study visit
Number of Participants With Clinically Significant Physical Examination Findings
measured From baseline through end of study visit
Number of Participants With Ketamine-Related Side Effects as Assessed by the Ketamine Side Effect Tool (KSET)
measured From baseline through end of study visit
Change From Baseline in Bowdle Visual Analog Scale (VAS) Score
measured From baseline through end of study visit
Related
Permalink · MIRA's whole pipeline · Catalyst calendar · Every registered study · What changed