NCT07699120Enrolling By Invitation1 期
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
Biopharmaceutical Research Company1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年6月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety and tolerability of BRC-002 after single and multiple dose administration in healthy participants
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Placebo (Drug)
Repeat Dose (RD)
Experimental
Repeat Dose (RD) study to evaluate the safety, tolerability and pharmacokinetics of repeated doses of BRC-002 vs. placebo
干预措施: Placebo (Drug)
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
干预措施: BRC-002 (Drug)
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.
干预措施: BRC-002 (Drug)
Repeat Dose (RD)
Experimental
Repeat Dose (RD) study to evaluate the safety, tolerability and pharmacokinetics of repeated doses of BRC-002 vs. placebo
干预措施: BRC-002 (Drug)
结局指标
主要结局
Safety and tolerability of BRC-002 after single and multiple dose administration in healthy participants
时间窗: 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.
次要结局
- 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)
- Area Under the Plasma Concentration-Time Curve From 0 Hours to Infinity (AUC0-inf)(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)(Pre-dose up to 144 hours following the final dose)
- Apparent Volume of Distribution During the Terminal Elimination Phase (Vd/F)(Pre-dose up to 144 hours following the final dose)
- Apparent Oral Clearance From Plasma (CL/F)(Pre-dose up to 144 hours following the final dose)
- Apparent Elimination Half-Life (t½)(Pre-dose up to 144 hours following the final dose)
- Apparent Terminal Elimination Rate Constant (λz)(Pre-dose up to 144 hours following the final dose)
- Percentage of AUC Extrapolated From the Last Quantifiable Concentration to Infinity (AUC%extrap)(Pre-dose up to 144 hours following the final dose)
- Maximum Observed Plasma Concentration (Cmax) Under Fasted and Fed 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(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(Pre-dose up to 144 hours following the final dose)
- Time to Maximum Plasma Concentration (tmax) Under Fasted and Fed Conditions(Pre-dose up to 144 hours following the final dose)
- Apparent Elimination Half-Life (t½) Under Fasted and Fed Conditions(Pre-dose up to 144 hours following the final dose)
- Apparent Terminal Elimination Rate Constant (λz) Under Fasted and Fed Conditions(Pre-dose up to 144 hours following the final dose)
研究者
研究点 (1)
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