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CHI-202, CHI-101

Phase 2

Delayed Onset Muscle Soreness (DOMS) | Unknown | Pain |Canopy Growth Corporation|Trials Updated: Feb 16, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

CHI-202, CHI-101 clinical trials

CHI-202, CHI-101 · 1 trial · 1 indication

Phase 2 1
NCT05026164Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical ActivityDelayed Onset Muscle Soreness (DOMS)
COMPLETED40 Analytics
PHASE2COMPLETED
Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity
Delayed Onset Muscle Soreness (DOMS)Unlock trial analytics

Study Endpoints

Primary Endpoints

Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
Day 2

Blood pressure is measure by the combination of systolic and diastolic measurements

Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
Day 2

Respiratory rate will be measured as breaths per minute

Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
Day 2

Heart rate will be measured as heart beats per minute

Total number of Adverse Events [Safety and Tolerability]
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]
Through study completion (Day 4)

Safety and tolerability will be assessed through Adverse Events and Serious Adverse Events

Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed) [Safety and Tolerability]
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)

Secondary Endpoints

Average soreness or discomfort intensity using the 11-point (0-10) NRS
Day 1 - post DOMS intervention
Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Day 2
Worst soreness or discomfort intensity using the 11-point (0-10) NRS
Day 1 - post DOMS intervention
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
ActiveACTIVE_COMPARATORCHI-202. Participants will drink one 7.0g CHI-202 powder sachet mixed into 16oz of water twice daily.
PlaceboPLACEBO_COMPARATORCHI-101. Participants will drink one 7.0g CHI-101 powder sachet mixed into 16oz of water twice daily.

Interventions

NameTypeDescription
CHI-202DIETARY_SUPPLEMENTBlend of cannabinoids \& other ingredients
CHI-101DIETARY_SUPPLEMENTPlacebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Is a healthy adult aged 18-65 years, inclusive, at the time of screening. 2. 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. 3. Has a body mass index between 18 and 35 kg/m2 (inclusive). 4. Is...

Countries:United States
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Frequently asked questions about CHI-202, CHI-101

What is CHI-202 used for?

CHI-202 is an investigational drug being studied for Delayed Onset Muscle Soreness (DOMS), a condition of muscle pain and stiffness that occurs after intense physical activity. It is being developed as a potential treatment to support recovery from physical activity and is currently in Phase 2 clinical development.

Who makes CHI-202?

CHI-202 is being developed by Canopy Growth Corporation, a company traded on the stock exchange under the ticker symbol CGC. The company is conducting clinical research on this investigational drug for the treatment of Delayed Onset Muscle Soreness (DOMS).

What phase is CHI-202 in?

CHI-202 is in Phase 2 clinical development. A Phase 2 clinical trial has been completed to assess the safety, tolerability, and effects of CHI-202 for supporting recovery from physical activity in patients with Delayed Onset Muscle Soreness (DOMS).

What clinical trials is CHI-202 in?

CHI-202 has one completed clinical trial registered under NCT05026164, titled "Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity." This Phase 2 trial enrolled 40 participants with Delayed Onset Muscle Soreness (DOMS) and was not randomized, double-blind, or controlled.

Is CHI-202 the same as CHI-101?

CHI-202 and CHI-101 are both investigational drugs being developed by Canopy Growth Corporation, but they are distinct drug candidates. CHI-202 is being studied for Delayed Onset Muscle Soreness (DOMS), while CHI-101 is a separate compound with its own development program.