NCT05026164

Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Canopy Growth Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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).

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.

Conditions

• Delayed Onset Muscle Soreness (DOMS)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CHI-202	Blend of cannabinoids \& other ingredients
DIETARY_SUPPLEMENT	CHI-101	Placebo

Timeline

• Start date: 2021-12-13
• Primary completion: 2022-02-04
• Completion: 2022-02-04
• First posted: 2021-08-30
• Last updated: 2022-02-16

Locations

1 site across 1 country: United States