A Randomized, Double-Blind, Placebo-Controlled, Repeated-Dose Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed) [Safety and Tolerability]
研究概览
简要总结
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS).
详细描述
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS). Healthy adults ages 18-65 years who are exercise-trained (self-report exercising at least 3 times per week for at least 30 minutes per session for the past year) will be recruited from existing panels of participants from past studies, local advertisements, and social media targeted advertisements. Those who meet the inclusion/exclusion criteria will be enrolled into the study, scheduled for the Exercise Visit (Study Visit 1; Day 0) within 2 weeks of screening, and randomized to active vs. placebo IP condition in a 1:1 ratio. One repetition maximum (1RM) method, the maximum amount of weight one can lift in a single repetition for a given exercise, will be used in order to induce DOMS. Following the completion of the Exercise Visit, participants will be scheduled for 3 follow-up visits that will occur 1, 2, and 3 days post-Exercise Visit. Participants will consume 7 scheduled doses of the study IP to which they have been randomly assigned (i.e., active or placebo) with instruction to consume the study IP prior to the exercise at Study Visit 1, at 8PM (±1 hour) that night, and then at 8AM and 8PM (±1 hour) every day until their final study visit. The last dose will occur at 8AM (±1 hour) on Day 4, i.e., immediately prior to Study Visit 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is a healthy adult aged 18-65 years, inclusive, at the time of screening.
- •Is exercise-trained, i.e., self-reports exercising at least 3 times per week for at least 30 minutes per session for the past year.
- •Has a body mass index between 18 and 35 kg/m2 (inclusive).
- •Is judged by the Investigator to be in generally good health at screening based on participants' self-reported medical history.
- •Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
排除标准
- •Women who are pregnant, lactating, breastfeeding, or planning a pregnancy.
- •Women of childbearing potential, or men who are sexually active with a woman of childbearing potential, who are unwilling or unable to use an acceptable method of contraception (abstinence or the use of a highly effective method of contraception, including hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, or intrauterine device) from at least 21 days prior to the first dose of study medication until 28 days after the last dose of study medication.
- •Has a history of epilepsy, hepatitis, clinically significant hepatic or renal impairment, or human immunodeficiency virus.
- •Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for the month prior to the Exercise Visit.
- •Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP.
- •Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP (e.g., coconut; coconut oil; medium-chain triglycerides).
- •Has musculoskeletal issues that might impede performing maximal elbow flexion exercises.
- •Has taken a medication with likely CBD-interactions, including warfarin, clobazam, valproic acid, phenobarbital, mTOR inhibitors, oral tacrolimus, and St. John's Wort within 30 days of the Exercise Visit or during the study.
- •Has taken grapefruit products and/or Seville oranges within the 7 days prior to dosing with study IP.
- •Has used cannabis, synthetic cannabinoid or cannabinoid analogues (e.g., dronabinol, nabilone), hemp products, synthetic cannabinoid receptor agonists (e.g., spice, K2), or any CBD- or THC-containing product (e.g., Sativex, Epidiolex) within 4 weeks of the Exercise Visit or during the study.
- •Has a history or current diagnosis of a significant psychiatric disorder that would, in the opinion of the Investigator, affect the subject's ability to comply with the study requirements.
- •Endorses current suicidal intent.
- •Has participated in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in another investigational product or device study during the course of this study.
- •Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
- •Has a positive result on urine drug screen for cocaine, amphetamine, methamphetamine, THC, and opiates at the first study visit.
研究组 & 干预措施
Active
CHI-202. Participants will drink one 7.0g CHI-202 powder sachet mixed into 16oz of water twice daily.
干预措施: CHI-202 (Dietary Supplement)
Placebo
CHI-101. Participants will drink one 7.0g CHI-101 powder sachet mixed into 16oz of water twice daily.
干预措施: CHI-101 (Dietary Supplement)
结局指标
主要结局
Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed) [Safety and Tolerability]
时间窗: Through study completion (Day 4)
Safety and tolerability will be assessed through Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed)
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
时间窗: Day 4
Heart rate will be measured as heart beats per minute
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
时间窗: Day 4
Blood pressure is measure by the combination of systolic and diastolic measurements
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
时间窗: Day 4
Respiratory rate will be measured as breaths per minute
Total number of Adverse Events [Safety and Tolerability]
时间窗: Through study completion (Day 4)
Safety and tolerability will be assessed through Adverse Events and Serious Adverse Events
Total number of participants with Adverse Events [Safety and Tolerability]
时间窗: Through study completion (Day 4)
Safety and tolerability will be assessed through Adverse Events and Serious Adverse Events
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
时间窗: Day 2
Blood pressure is measure by the combination of systolic and diastolic measurements
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
时间窗: Day 3
Blood pressure is measure by the combination of systolic and diastolic measurements
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
时间窗: Day 2
Respiratory rate will be measured as breaths per minute
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
时间窗: Day 3
Respiratory rate will be measured as breaths per minute
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
时间窗: Day 2
Heart rate will be measured as heart beats per minute
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
时间窗: Day 3
Heart rate will be measured as heart beats per minute
次要结局
- Self-reported sleep quality using the 11-point (0-10) NRS(Day 4)
- Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS(Day 4)
- Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS(Day 4)
- Passive range of motion(Day 4)
- Muscle circumference(Day 4)
- Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS(Day 4)
- Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS(Day 4)
- Self-reported alertness upon waking via a sleep diary(Day 4)
- Relaxed elbow angle(Day 4)
- Average soreness or discomfort intensity using the 11-point (0-10) NRS(Day 1 - post DOMS intervention)
- Worst soreness or discomfort intensity using the 11-point (0-10) NRS(Day 1 - post DOMS intervention)
- Self-reported sleep duration via a sleep diary(Day 4)
- Self-reported latency to sleep onset via a sleep diary(Day 4)
- Self-reported sleep continuity via a sleep diary(Day 4)
- Pressure threshold(Day 4)
- Active range of motion(Day 4)
- Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS(Day 4)
- Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS(Day 4)
- Average stiffness intensity using the 11-point (0-10) NRS(Day 1 - post DOMS intervention)
- Worst stiffness intensity using the 11-point (0-10) NRS(Day 1 - post DOMS intervention)
- Mood using the Profile of Mood States(Day 4)
- Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS(Day 2)
- Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS(Day 3)
- Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS(Day 2)
- Self-reported sleep quality using the 11-point (0-10) NRS(Day 3)
- Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS(Day 3)
- Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS(Day 2)
- Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS(Day 3)
- Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS(Day 2)
- Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS(Day 3)
- Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS(Day 2)
- Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS(Day 3)
- Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS(Day 2)
- Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS(Day 3)
- Self-reported sleep quality using the 11-point (0-10) NRS(Day 2)
- Self-reported sleep duration via a sleep diary(Day 2)
- Self-reported latency to sleep onset via a sleep diary(Day 2)
- Self-reported sleep continuity via a sleep diary(Day 2)
- Pressure threshold(Day 1 - post DOMS intervention)
- Self-reported alertness upon waking via a sleep diary(Day 2)
- Self-reported sleep duration via a sleep diary(Day 3)
- Self-reported latency to sleep onset via a sleep diary(Day 3)
- Self-reported sleep continuity via a sleep diary(Day 3)
- Self-reported alertness upon waking via a sleep diary(Day 3)
- Pressure threshold(Day 2)
- Pressure threshold(Day 3)
- Relaxed elbow angle(Day 1 - post DOMS intervention)
- Active range of motion(Day 1 - post DOMS intervention)
- Passive range of motion(Day 1 - post DOMS intervention)
- Relaxed elbow angle(Day 2)
- Active range of motion(Day 2)
- Passive range of motion(Day 2)
- Relaxed elbow angle(Day 3)
- Active range of motion(Day 3)
- Passive range of motion(Day 3)
- Muscle circumference(Day 1 - post DOMS intervention)
- Muscle circumference(Day 2)
- Muscle circumference(Day 3)
- Mood using the Profile of Mood States(Day 1 - post DOMS intervention)
- Mood using the Profile of Mood States(Day 2)
- Mood using the Profile of Mood States(Day 3)