A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Cannabidiol Capsules (AVAT-121) and Epidyolex® in Healthy Adults

This Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of AVAT-121 in healthy adults. The study includes three parts: Part A: single ascending dose. Part B: comparison of AVAT-121 with Epidyolex®, under fed and fasted conditions. Part C: multiple-dose testing Up to 44 participants will be enrolled in this study.

Inclusion Criteria: * Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 60 kg * Not pregnant or breastfeeding, or willing to cease breastfeeding * Woman of childbearing potential (WOCBP) or fertile man agrees to use a male condom combined with a highly effective method of contraception from the start of Screening (hormonal contraceptives must have commenced at least 30 days prior to Screening) until 90 days after the last dose of IP. * Adequate venous access in both arms. Inclusion Criteria Specific to Part C: * Japanese participants must be up to third generation Japanese lineage, which is defined as, the participant's, biological grandparents as 100% Japanese, and were all born in Japan. Non-Japanese participants must not meet these criteria. Exclusion Criteria: * Any history or evidence of any clinically significant renal, hepatic, gastrointestinal (history of appendectomy is permitted), cardiovascular, respiratory (history of childhood asthma is permitted), hematologic, dermatologic (history of eczema is permitted provided there has been no use of topical steroid creams within 3 months prior to Screening), autoimmune, endocrine (history of fully resolved gestational diabetes is permitted), inflammatory, neurological, or any uncontrolled medical condition that, in the opinion of the PI or designee, could jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data. * Any psychiatric condition requiring pharmacological management within 6 months prior to Screening, current or prior psychotic disorder, schizophrenia or bipolar disorders, or current suicidal ideation or behavior including a response of "Yes" to C-SSRS Questions 4 or 5, or any positive response to the suicidal behavior section of the C-SSRS. * Participants with current or past history of acute or chronic liver disease of any etiology. * Donation of plasma within 7 days prior to first administration of IP or donation or loss of 500 mL or more of whole blood within 30 days prior to first administration of IP. * Fever (tympanic temperature \> 38°C) or symptomatic viral or bacterial infection within 14 days prior to Screening. * History of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening. * History or presence of a condition associated with significant immunosuppression. * Positive urine drug test (including barbiturates, tetrahydrocannabinol \[THC\], amphetamines, methamphetamines, methadone, methylenedioxymethamphetamine \[MDMA\], phencyclidine \[PCP\] benzodiazepines, opiates, tricyclic antidepressants and cocaine), urine cotinine test or alcohol breath test * History or evidence or renal disease or estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 at Screening, calculated by the 2021 chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine equation.