- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05026164
Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity
February 15, 2022 updated by: Canopy Growth Corporation
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Boca Raton, Florida, United States, 33432
- International Society for Sports Nutrition
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active
CHI-202.
Participants will drink one 7.0g CHI-202 powder sachet mixed into 16oz of water twice daily.
|
Blend of cannabinoids & other ingredients
|
Placebo Comparator: Placebo
CHI-101.
Participants will drink one 7.0g CHI-101 powder sachet mixed into 16oz of water twice daily.
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
Time Frame: Day 2
|
Blood pressure is measure by the combination of systolic and diastolic measurements
|
Day 2
|
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
Time Frame: Day 3
|
Blood pressure is measure by the combination of systolic and diastolic measurements
|
Day 3
|
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
Time Frame: Day 4
|
Blood pressure is measure by the combination of systolic and diastolic measurements
|
Day 4
|
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
Time Frame: Day 2
|
Respiratory rate will be measured as breaths per minute
|
Day 2
|
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
Time Frame: Day 3
|
Respiratory rate will be measured as breaths per minute
|
Day 3
|
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
Time Frame: Day 4
|
Respiratory rate will be measured as breaths per minute
|
Day 4
|
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
Time Frame: Day 2
|
Heart rate will be measured as heart beats per minute
|
Day 2
|
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
Time Frame: Day 3
|
Heart rate will be measured as heart beats per minute
|
Day 3
|
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
Time Frame: Day 4
|
Heart rate will be measured as heart beats per minute
|
Day 4
|
Total number of Adverse Events [Safety and Tolerability]
Time Frame: Through study completion (Day 4)
|
Safety and tolerability will be assessed through Adverse Events and Serious Adverse Events
|
Through study completion (Day 4)
|
Total number of participants with Adverse Events [Safety and Tolerability]
Time Frame: Through study completion (Day 4)
|
Safety and tolerability will be assessed through Adverse Events and Serious Adverse Events
|
Through study completion (Day 4)
|
Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed) [Safety and Tolerability]
Time Frame: 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)
|
Through study completion (Day 4)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average soreness or discomfort intensity using the 11-point (0-10) NRS
Time Frame: Day 1 - post DOMS intervention
|
Self-reported average soreness or discomfort intensity using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
|
Day 1 - post DOMS intervention
|
Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Time Frame: Day 2
|
Self-reported average soreness or discomfort intensity over the last 24 hours using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
|
Day 2
|
Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Time Frame: Day 3
|
Self-reported average soreness or discomfort intensity over the last 24 hours using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
|
Day 3
|
Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Time Frame: Day 4
|
Self-reported average soreness or discomfort intensity over the last 24 hours using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
|
Day 4
|
Worst soreness or discomfort intensity using the 11-point (0-10) NRS
Time Frame: Day 1 - post DOMS intervention
|
Self-reported worst soreness or discomfort intensity using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
|
Day 1 - post DOMS intervention
|
Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Time Frame: Day 2
|
Self-reported worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
|
Day 2
|
Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Time Frame: Day 3
|
Self-reported worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
|
Day 3
|
Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Time Frame: Day 4
|
Self-reported worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
|
Day 4
|
Average stiffness intensity using the 11-point (0-10) NRS
Time Frame: Day 1 - post DOMS intervention
|
Self-reported average stiffness intensity using the 11-point (0-10) NRS where 10 is most stiffness intensity
|
Day 1 - post DOMS intervention
|
Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Time Frame: Day 2
|
Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity
|
Day 2
|
Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Time Frame: Day 3
|
Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity
|
Day 3
|
Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Time Frame: Day 4
|
Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity
|
Day 4
|
Worst stiffness intensity using the 11-point (0-10) NRS
Time Frame: Day 1 - post DOMS intervention
|
Self-reported worst stiffness intensity using the 11-point (0-10) NRS where 10 is most stiffness intensity
|
Day 1 - post DOMS intervention
|
Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Time Frame: Day 2
|
Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity
|
Day 2
|
Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Time Frame: Day 3
|
Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity
|
Day 3
|
Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Time Frame: Day 4
|
Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity
|
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
Time Frame: Day 2
|
Self-reported 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 where 10 is most interference
|
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
Time Frame: Day 3
|
Self-reported 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 where 10 is most interference
|
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
Time Frame: Day 4
|
Self-reported 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 where 10 is most interference
|
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
Time Frame: Day 2
|
Self-reported 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 where 10 is most interference
|
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
Time Frame: Day 3
|
Self-reported 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 where 10 is most interference
|
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
Time Frame: Day 4
|
Self-reported 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 where 10 is most interference
|
Day 4
|
Self-reported sleep quality using the 11-point (0-10) NRS
Time Frame: Day 2
|
Self-reported sleep quality using the 11-point (0-10) NRS where 10 is best sleep quality
|
Day 2
|
Self-reported sleep quality using the 11-point (0-10) NRS
Time Frame: Day 3
|
Self-reported sleep quality using the 11-point (0-10) NRS where 10 is best sleep quality
|
Day 3
|
Self-reported sleep quality using the 11-point (0-10) NRS
Time Frame: Day 4
|
Self-reported sleep quality using the 11-point (0-10) NRS where 10 is best sleep quality
|
Day 4
|
Self-reported sleep duration via a sleep diary
Time Frame: Day 2
|
Self-reported sleep duration measured in minutes via a sleep diary
|
Day 2
|
Self-reported latency to sleep onset via a sleep diary
Time Frame: Day 2
|
Self-reported latency to sleep onset measured in minutes via a sleep diary
|
Day 2
|
Self-reported sleep continuity via a sleep diary
Time Frame: Day 2
|
Self-reported sleep continuity measured in minutes via a sleep diary
|
Day 2
|
Self-reported alertness upon waking via a sleep diary
Time Frame: Day 2
|
Self-reported alertness upon waking via a sleep diary.
Alertness is measure on a scale of 1 to 3 where 1 is Alert, 2 is Alert but a little tired and 3 is Sleepy
|
Day 2
|
Self-reported sleep duration via a sleep diary
Time Frame: Day 3
|
Self-reported sleep duration measured in minutes via a sleep diary
|
Day 3
|
Self-reported latency to sleep onset via a sleep diary
Time Frame: Day 3
|
Self-reported latency to sleep onset measured in minutes via a sleep diary
|
Day 3
|
Self-reported sleep continuity via a sleep diary
Time Frame: Day 3
|
Self-reported sleep continuity measured in minutes via a sleep diary
|
Day 3
|
Self-reported alertness upon waking via a sleep diary
Time Frame: Day 3
|
Self-reported alertness upon waking via a sleep diary.
Alertness is measure on a scale of 1 to 3 where 1 is Alert, 2 is Alert but a little tired and 3 is Sleepy
|
Day 3
|
Self-reported sleep duration via a sleep diary
Time Frame: Day 4
|
Self-reported sleep duration measured in minutes via a sleep diary
|
Day 4
|
Self-reported latency to sleep onset via a sleep diary
Time Frame: Day 4
|
Self-reported latency to sleep onset measured in minutes via a sleep diary
|
Day 4
|
Self-reported sleep continuity via a sleep diary
Time Frame: Day 4
|
Self-reported sleep continuity measured in minutes via a sleep diary
|
Day 4
|
Self-reported alertness upon waking via a sleep diary
Time Frame: Day 4
|
Self-reported alertness upon waking via a sleep diary.
Alertness is measure on a scale of 1 to 3 where 1 is Alert, 2 is Alert but a little tired and 3 is Sleepy
|
Day 4
|
Pressure threshold
Time Frame: Day 1 - post DOMS intervention
|
Pressure threshold measured with a 25-lb algometer
|
Day 1 - post DOMS intervention
|
Pressure threshold
Time Frame: Day 2
|
Pressure threshold measured with a 25-lb algometer
|
Day 2
|
Pressure threshold
Time Frame: Day 3
|
Pressure threshold measured with a 25-lb algometer
|
Day 3
|
Pressure threshold
Time Frame: Day 4
|
Pressure threshold measured with a 25-lb algometer
|
Day 4
|
Relaxed elbow angle
Time Frame: Day 1 - post DOMS intervention
|
Relaxed elbow angle measured with a goniometer in degrees
|
Day 1 - post DOMS intervention
|
Active range of motion
Time Frame: Day 1 - post DOMS intervention
|
Active range of motion measured with a goniometer in degrees
|
Day 1 - post DOMS intervention
|
Passive range of motion
Time Frame: Day 1 - post DOMS intervention
|
Passive range of motion measured with a goniometer in degrees
|
Day 1 - post DOMS intervention
|
Relaxed elbow angle
Time Frame: Day 2
|
Relaxed elbow angle measured with a goniometer in degrees
|
Day 2
|
Active range of motion
Time Frame: Day 2
|
Active range of motion measured with a goniometer in degrees
|
Day 2
|
Passive range of motion
Time Frame: Day 2
|
Passive range of motion measured with a goniometer in degrees
|
Day 2
|
Relaxed elbow angle
Time Frame: Day 3
|
Relaxed elbow angle measured with a goniometer in degrees
|
Day 3
|
Active range of motion
Time Frame: Day 3
|
Active range of motion measured with a goniometer in degrees
|
Day 3
|
Passive range of motion
Time Frame: Day 3
|
Passive range of motion measured with a goniometer in degrees
|
Day 3
|
Relaxed elbow angle
Time Frame: Day 4
|
Relaxed elbow angle measured with a goniometer in degrees
|
Day 4
|
Active range of motion
Time Frame: Day 4
|
Active range of motion measured with a goniometer in degrees
|
Day 4
|
Passive range of motion
Time Frame: Day 4
|
Passive range of motion measured with a goniometer in degrees
|
Day 4
|
Muscle circumference
Time Frame: Day 1 - post DOMS intervention
|
Muscle circumference
|
Day 1 - post DOMS intervention
|
Muscle circumference
Time Frame: Day 2
|
Muscle circumference
|
Day 2
|
Muscle circumference
Time Frame: Day 3
|
Muscle circumference
|
Day 3
|
Muscle circumference
Time Frame: Day 4
|
Muscle circumference
|
Day 4
|
Mood using the Profile of Mood States
Time Frame: Day 1 - post DOMS intervention
|
Mood using the Profile of Mood States
|
Day 1 - post DOMS intervention
|
Mood using the Profile of Mood States
Time Frame: Day 2
|
Mood using the Profile of Mood States
|
Day 2
|
Mood using the Profile of Mood States
Time Frame: Day 3
|
Mood using the Profile of Mood States
|
Day 3
|
Mood using the Profile of Mood States
Time Frame: Day 4
|
Mood using the Profile of Mood States
|
Day 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Erica Peters, PhD, Canopy Growth Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2021
Primary Completion (Actual)
February 4, 2022
Study Completion (Actual)
February 4, 2022
Study Registration Dates
First Submitted
July 26, 2021
First Submitted That Met QC Criteria
August 23, 2021
First Posted (Actual)
August 30, 2021
Study Record Updates
Last Update Posted (Actual)
February 16, 2022
Last Update Submitted That Met QC Criteria
February 15, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 710US-1311
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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