Healthy Adult ParticipantsPhase 1NCT07699120
Evaluation of BRC-002 Safety, Tolerability, Pharmacokinetics, and Food Effects in Healthy Participants
A Phase 1 study testing BRC-002 in people with Healthy Adult Participants, run by Biopharmaceutical Research Company at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- BRC-002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2026to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Healthy Adult Participants
- Being tested
- BRC-002, Placebo
- Keywords
- botanical, cannabis, BRC-002, botanical drug, cannabinoid
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRC-002Drug
Also called botanical drug from cannabis
Oral liquid standardized cannabis-derived botanical drug product manufactured according to cGMP
PlaceboDrug
Oral liquid placebo product manufactured according to cGMP
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Drug: BRC-002; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-dose up to 144 hours following the final dose
Secondary outcomes (18)
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration of BRC-002 following administration
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-dose up to 144 hours following the final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start15 Jun 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biopharmaceutical Research Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699120
- Sponsor's protocol ID
- RPC25PH101
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the publication of study results
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07699120
- Acronym / sponsor ID
- RPC25PH101
- Conditions
- Healthy Adult Participants
- Keywords
- botanical, cannabis, BRC-002, botanical drug, cannabinoid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Biopharmaceutical Research CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) | Experimental | Drug: BRC-002, Drug: PlaceboSingle Ascending Dose (SAD) study to evaluate the safety, tolerability and pharmacokinetics of increasing single doses of BRC-002 vs. placebo |
| Food Effect (FE) | Experimental | Drug: BRC-002Food Effect (FE) study to evaluate the impact of a high-fat, high-calorie meal on the safety, tolerability and pharmacokinetics of BRC-002. |
| Repeat Dose (RD) | Experimental | Drug: BRC-002, Drug: PlaceboRepeat Dose (RD) study to evaluate the safety, tolerability and pharmacokinetics of repeated doses of BRC-002 vs. placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRC-002Also: botanical drug from cannabisOral liquid standardized cannabis-derived botanical drug product manufactured according to cGMP | Drug | Food Effect (FE), Repeat Dose (RD), Single Ascending Dose (SAD) |
| PlaceboOral liquid placebo product manufactured according to cGMP | Drug | Repeat Dose (RD), Single Ascending Dose (SAD) |
Primary outcome
Safety and tolerability of BRC-002 after single and multiple dose administration in healthy participants
Time frame: Pre-dose up to 144 hours following the final dose
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.
18 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose up to 144 hours following the final dose
Dose-Normalized Maximum Observed Plasma Concentration (Cmax_D)
Time frame: Pre-dose up to 144 hours following the final dose
Time to Maximum Plasma Concentration (tmax)
Time frame: 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)
Time frame: 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)
Time frame: Pre-dose up to 144 hours following the final dose
Area Under the Plasma Concentration-Time Curve From 0 Hours to Infinity (AUC0-inf)
Time frame: 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)
Time frame: Pre-dose up to 144 hours following the final dose
Apparent Volume of Distribution During the Terminal Elimination Phase (Vd/F)
Time frame: Pre-dose up to 144 hours following the final dose
Apparent Oral Clearance From Plasma (CL/F)
Time frame: Pre-dose up to 144 hours following the final dose
Apparent Elimination Half-Life (t½)
Time frame: Pre-dose up to 144 hours following the final dose
Apparent Terminal Elimination Rate Constant (λz)
Time frame: Pre-dose up to 144 hours following the final dose
Percentage of AUC Extrapolated From the Last Quantifiable Concentration to Infinity (AUC%extrap)
Time frame: Pre-dose up to 144 hours following the final dose
Maximum Observed Plasma Concentration (Cmax) Under Fasted and Fed Conditions
Time frame: 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
Time frame: 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
Time frame: Pre-dose up to 144 hours following the final dose
Time to Maximum Plasma Concentration (tmax) Under Fasted and Fed Conditions
Time frame: Pre-dose up to 144 hours following the final dose
Apparent Elimination Half-Life (t½) Under Fasted and Fed Conditions
Time frame: Pre-dose up to 144 hours following the final dose
Apparent Terminal Elimination Rate Constant (λz) Under Fasted and Fed Conditions
Time frame: Pre-dose up to 144 hours following the final dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Website of the study Sponsor, Biopharmaceutical Research CompanyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Only IPD used in the publication of study results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BRC-002 in people with Healthy Adult Participants, run by Biopharmaceutical Research Company at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of BRC-002 after single and multiple dose administration in healthy participants (time frame: Pre-dose up to 144 hours following the final dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.