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

NCT07699120 | Enrolling By Invitation Phase 1 DMC FDA Drug

• 1 other identifier: RPC25PH101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult Participants

Keywords

botanical; cannabis; BRC-002; botanical drug; cannabinoid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Maximum Observed Plasma Concentration (Cmax)

  Pre-dose up to 144 hours following the final dose

• Dose-Normalized Maximum Observed Plasma Concentration (Cmax_D)

  Pre-dose up to 144 hours following the final dose

• Time to Maximum Plasma Concentration (tmax)

  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)

  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)

  Pre-dose up to 144 hours following the final dose

Study Arms (3)

Single Ascending Dose (SAD)

EXPERIMENTAL

Single Ascending Dose (SAD) study to evaluate the safety, tolerability and pharmacokinetics of increasing single doses of BRC-002 vs. placebo

Drug: BRC-002; Drug: Placebo

Food Effect (FE)

EXPERIMENTAL

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

Repeat Dose (RD)

EXPERIMENTAL

Repeat Dose (RD) study to evaluate the safety, tolerability and pharmacokinetics of repeated doses of BRC-002 vs. placebo

Drug: BRC-002; Drug: Placebo

Interventions

BRC-002 DRUG

Oral liquid standardized cannabis-derived botanical drug product manufactured according to cGMP

Also known as: botanical drug from cannabis

Food Effect (FE); Repeat Dose (RD); Single Ascending Dose (SAD)

Placebo DRUG

Oral liquid placebo product manufactured according to cGMP

Repeat Dose (RD); Single Ascending Dose (SAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biopharmaceutical Research Company: lead

Study Sites (1)

Bio Pharma Research Inc.

Toronto, Ontario, M9L 3A2, Canada

Location

Related Links

• Website of the study Sponsor, Biopharmaceutical Research Company

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 13, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)