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.
Clinically healthy participants (male and female) aged ≥ 18 to ≤ 65 years at the time of signing the informed consent.
Research participants with no history of clinically significant cardiac, endocrine, gastrointestinal, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, or renal diseases or comorbidity of significance at the discretion of the Principal Investigator (or his/her delegate). The following medical history are permitted at the discretion of the Principal Investigator: history of childhood asthma; prior history of cholecystectomy; history of eczema with no use of steroid creams for 3 months prior to screening; history of fully resolved gestational diabetes; current or history of ADHD, anxiety or antidepression ( stable condition with no use of antidepressants 6 months prior to screening)
Be able and willing to read, understand, sign, and date the Informed Consent Form prior to entering the study.
Have adequate venous access for blood sampling.
Research participants with inflammatory or ulcerative disease in the oral cavity that may affect the absorption of the sublingual presentation.
History of allergic reactions, anaphylactic reactions, severe systemic hypersensitivity, or any allergic reaction that, in the opinion of the Principal Investigator or his or her delegate, is likely to be exacerbated by the study drug.
History of hypersensitivity to ketamine or any of the WafermineTM excipients.
Elective procedures or surgeries scheduled after signing the Informed Consent Form and until the safety follow-up call [3 days ± 1 day after the 36.0-hour third period is taken].
iX Biopharma Ltd.
Lead sponsor
United States Department of Defense
Collaborator