Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Centre Study of Single and Repeated Dosing of Ascending Doses, to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects

This is a prospective, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of oral Ketamir-2 in healthy adult participants. The study includes single ascending dose cohorts and multiple ascending dose cohorts.

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.