By InvitationPhase 1

Evaluation of BRC-002 Safety, Tolerability, Pharmacokinetics, and Food Effects in Healthy Participants

Canada50 participantsStarted 2026-06-15

Plain-language summary

This study will evaluate the safety and tolerability of BRC-002, an investigational botanical drug from cannabis, in healthy adults. The study will also assess how the body processes BRC-002 and whether taking it with food affects how it is absorbed or metabolized. The results of this study will help support further clinical development of BRC-002 and guide dose selection in patient populations.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Hepati…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability of BRC-002 after single and multiple dose administration in healthy participants

Timeframe: Pre-dose up to 144 hours following the final dose

Trial details

NCT IDNCT07699120

SponsorBiopharmaceutical Research Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More Healthy Adult Participants trials