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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Repeat Dose and Randomized, Open-label, Crossover, Food Effect Safety, Tolerability, and Pharmacokinetic Study of BRC-002 in Healthy Participants

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy Adult Participants
• Intervention / Treatment: Drug: BRC-002; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M9L 3A2
      • Bio Pharma Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Ascending Dose (SAD); Single Ascending Dose (SAD) study to evaluate the safety, tolerability and pharmacokinetics of increasing single doses of BRC-002 vs. placebo	Drug: BRC-002; Oral liquid standardized cannabis-derived botanical drug product manufactured according to cGMP; Other Names: botanical drug from cannabis; Drug: Placebo; Oral liquid placebo product manufactured according to cGMP
Experimental: Food Effect (FE); Food Effect (FE) study to evaluate the impact of a high-fat, high-calorie meal on the safety, tolerability and pharmacokinetics of BRC-002.	Drug: BRC-002; Oral liquid standardized cannabis-derived botanical drug product manufactured according to cGMP; Other Names: botanical drug from cannabis
Experimental: Repeat Dose (RD); Repeat Dose (RD) study to evaluate the safety, tolerability and pharmacokinetics of repeated doses of BRC-002 vs. placebo	Drug: BRC-002; Oral liquid standardized cannabis-derived botanical drug product manufactured according to cGMP; Other Names: botanical drug from cannabis; Drug: Placebo; Oral liquid placebo product manufactured according to cGMP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of BRC-002 after single and multiple dose administration in healthy participants	Incidence of adverse events, including serious AEs and AEs of special interest. Clinically significant changes in clinical laboratory tests, vital signs, electrocardiograms, and physical examinations.	Pre-dose up to 144 hours following the final dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Maximum observed plasma concentration of BRC-002 following administration	Pre-dose up to 144 hours following the final dose
Dose-Normalized Maximum Observed Plasma Concentration (Cmax_D)	Maximum observed plasma concentration of BRC-002 normalized to the administered dose	Pre-dose up to 144 hours following the final dose
Time to Maximum Plasma Concentration (tmax)	Time from dosing to the maximum observed plasma concentration of BRC-002	Pre-dose up to 144 hours following the final dose
Area Under the Plasma Concentration-Time Curve From 0 Hours to the Time of the Last Quantifiable Concentration (AUC0-tlast)	Area under the plasma concentration-time curve of BRC-002 from time zero to the last quantifiable concentration	Pre-dose up to 144 hours following the final dose
Dose-Normalized Area Under the Plasma Concentration-Time Curve From 0 Hours to the Time of the Last Quantifiable Concentration (AUC0-tlast_D)	Area under the plasma concentration-time curve of BRC-002 from time zero to the last quantifiable concentration, normalized to the administered dose	Pre-dose up to 144 hours following the final dose
Area Under the Plasma Concentration-Time Curve From 0 Hours to Infinity (AUC0-inf)	Area under the plasma concentration-time curve of BRC-002 from time zero extrapolated to infinity	Pre-dose up to 144 hours following the final dose
Dose-Normalized Area Under the Plasma Concentration-Time Curve From 0 Hours to Infinity (AUC0-inf_D)	Area under the plasma concentration-time curve of BRC-002 from time zero extrapolated to infinity, normalized to the administered dose	Pre-dose up to 144 hours following the final dose
Apparent Volume of Distribution During the Terminal Elimination Phase (Vd/F)	Apparent volume of distribution of BRC-002 during the terminal elimination phase following extravascular administration	Pre-dose up to 144 hours following the final dose
Apparent Oral Clearance From Plasma (CL/F)	Apparent clearance of BRC-002 from plasma following extravascular administration	Pre-dose up to 144 hours following the final dose
Apparent Elimination Half-Life (t½)	Time required for the plasma concentration of BRC-002 to decrease by half during the terminal elimination phase	Pre-dose up to 144 hours following the final dose
Apparent Terminal Elimination Rate Constant (λz)	Terminal elimination rate constant of BRC-002 estimated from the terminal log-linear portion of the plasma concentration-time curve	Pre-dose up to 144 hours following the final dose
Percentage of AUC Extrapolated From the Last Quantifiable Concentration to Infinity (AUC%extrap)	Percentage of the total area under the plasma concentration-time curve of BRC-002 from time zero to infinity that is extrapolated from the last quantifiable concentration to infinity	Pre-dose up to 144 hours following the final dose
Maximum Observed Plasma Concentration (Cmax) Under Fasted and Fed Conditions	Maximum observed plasma concentration of BRC-002 following administration under fasted and fed (high-fat/high-calorie meal) conditions	Pre-dose up to 144 hours following the final dose
Area Under the Plasma Concentration-Time Curve From 0 Hours to the Time of the Last Quantifiable Concentration (AUC0-tlast) Under Fasted and Fed Conditions	Area under the plasma concentration-time curve of BRC-002 from time zero to the last quantifiable concentration following administration under fasted and fed (high-fat/high-calorie meal) conditions	Pre-dose up to 144 hours following the final dose
Area Under the Plasma Concentration-Time Curve From 0 Hours to Infinity (AUC0-inf) Under Fasted and Fed Conditions	Area under the plasma concentration-time curve of BRC-002 from time zero extrapolated to infinity following administration under fasted and fed (high-fat/high-calorie meal) conditions	Pre-dose up to 144 hours following the final dose
Time to Maximum Plasma Concentration (tmax) Under Fasted and Fed Conditions	Time from dosing to the maximum observed plasma concentration of BRC-002 following administration under fasted and fed (high-fat/high-calorie meal) conditions	Pre-dose up to 144 hours following the final dose
Apparent Elimination Half-Life (t½) Under Fasted and Fed Conditions	Time required for the plasma concentration of BRC-002 to decrease by half during the terminal elimination phase following administration under fasted and fed (high-fat/high-calorie meal) conditions	Pre-dose up to 144 hours following the final dose
Apparent Terminal Elimination Rate Constant (λz) Under Fasted and Fed Conditions	Terminal elimination rate constant of BRC-002 estimated from the terminal log-linear portion of the plasma concentration-time curve following administration under fasted and fed (high-fat/high-calorie meal) conditions	Pre-dose up to 144 hours following the final dose

Collaborators and Investigators

• Sponsor: Biopharmaceutical Research Company

Publications and helpful links

Helpful Links

• Website of the study Sponsor, Biopharmaceutical Research Company

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: cannabis; cannabinoid; botanical; botanical drug; BRC-002
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Marijuana Abuse
• Other Study ID Numbers: RPC25PH101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only IPD used in the publication of study results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No