Cannabis-Based drug BRC-002 enters first human safety trials

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and female volunteers, 18-55 years of age, inclusive. * Body mass index (BMI) ≥ 20 and ≤ 35 kg/m2, inclusive, and weight ≥50 kg. * Healthy, according to medical history, ECG, vital signs, laboratory results and physical examination. * No clinically significant abnormalities in laboratory values. * Ability to comprehend and be informed of the nature of the study; capable of giving written informed consent prior to any study related procedure. * Ability to fast for at least 14 hours and consume standard meals and/or high-fat, high-calorie meal, as applicable. * Agree to avoid use of cannabis or cannabis products for the duration of the study. * Non-pregnant, non-lactating, and agree to use an approved method of contraception, if applicable. Exclusion Criteria: * Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological (including immunocompromising), musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition. * Personal or significant family history of seizure disorder, neurodegenerative disease, brain trauma, brain infection, or any other condition known to increase the risk of seizures. * Presence of any clinically significant illness within 30 days prior to first dosing. * Known history or positive test result for human immunodeficiency virus (HIV), chronic Hepatitis B surface antigen, or Hepatitis C. * Smoking and/or use of any nicotine-containing products (e.g., vapes, e-cigarettes, gum, lozenges, patches, chewing tobacco, oral pouches, etc.) within 6 months prior to study drug administration. * Positive test result for drugs of abuse (THC, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol, or cotinine. * Positive pregnancy test for female participants. * Lifetime history of cannabis dependence. * Use of cannabis or cannabis products (including hemp or CBD products) within the past 30 days prior to Screening. * Lifetime history of major psychiatric illness, including schizophrenia, bipolar disorder, generalized anxiety disorder, major depression, panic disorder, substance use disorder, or psychosis. * Current suicidal ideation or past suicide attempt. * History of allergy, hypersensitivity, or intolerance to cannabis, CBD, or related products. * Past significant adverse reaction (allergic, anaphylactic, hypersensitivity, angioedema) or severe response to study drugs, their excipients, and to any other clinically significant drug or food. * Evidence of significant hepatic impairment as determined by clinically significant abnormalities in laboratory values. * Known history or presence of alcohol abuse or dependence within one year prior to first study drug administration; drug abuse or dependence; presence of any clinically significant dietary restrictions. * Abnormal diet patterns during the four weeks preceding the study. * Intolerance to and/or difficulty with blood sampling through venipuncture. * Recent blood donation (50-499 mL in the previous 30 days or 500 mL or more in the previous 56 days prior to first study drug administration). * Recent plasma donation by plasmapheresis (within 7 days prior to first study drug administration). * Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first study drug administration. * Use of any enzyme-modifying drugs and/or other products, including strong inhibitors or inducers of cytochrome P450 (CYP) enzymes in the previous 30 days before first study drug administration. * Use of any monoamine oxidase (MAO) inhibitors within 30 days prior to first study drug administration. * Use of clobazam, valproate, or mTOR inhibitors within 30 days prior to first study drug administration. * Use of any prescription medication or over-the-counter medications (including oral multivitamins, dietary and/or herbal supplements and teas) within 14 days prior to first study drug administration, except for medically acceptable contraceptive products. * Consumption of food or beverages containing grapefruit, Seville oranges, pineapple and/or pomelo within 10 days prior to first study drug administration. * Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds, and/or alcohol within 48 hours before dosing. * Any major surgery within 6 months prior to the start of the study. * Difficulty with oral drug administration. * Unable or unwilling to provide informed consent. * Tattoo or body piercing within 30 days prior to first study drug administration. * Any other conditions that, in the opinion of the PI/Sub-Investigator or Sponsor, would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study.