Clinical Trial

Pharmacokinetics and Safety of Single-Dose Wafermine™ (Ketamine Sublingual Wafer) in Healthy Subjects

Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated July 8, 2026 (before its estimated July 17, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a Phase 1, open-label, three-period crossover study evaluating the pharmacokinetics and safety of single-dose Wafermine™ (ketamine sublingual wafer) at dose levels of 25 mg, 50 mg, and 75 mg in healthy adult participants under fasting conditions. Participants will receive all three dose levels in a fixed ascending sequence during a single inpatient admission, with washout periods between doses. Pharmacokinetic sampling will be conducted over 36 hours following each dose.
Trial Details
NCT Number NCT07691372
Lead Sponsor iX Biopharma Ltd.
Collaborators: United States Department of Defense
Conditions Healthy Adult Participants
Enrollment 14 participants
Start Date 2026-06-09
Primary Completion 2026-07-17 (estimated)
Study Completion 2026-07-17 (estimated)
Updated on ClinicalTrials.gov 2026-07-08