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A Phase I, Double Blind, Randomized, Placebo Controlled, Maximal Dose Study to Determine the Safety, Tolerability of Topical Cream Containing MGC (Medical Grade Cannabis) in Healthy Volunteers

2016-11-30 15:45:16 | BioPortfolio

Summary

This single center, prospective, double-blind, placebo-controlled, randomized two parts study (part I and part II) will assess the safety of topical cream (3% CBD and 3% THC), applied twice daily (bid), in healthy subjects, for up to 6 treatment weeks and additional 2 follow-up weeks.

Description

The study is divided into 2 stages. Healthy subjects will be consented to participate in the study.

Part I is designed to evaluate the single dose safety assessment of single application of MGC cream in 26 healthy volunteers (intact skin) for up to 24 consecutive hours under admission conditions in the clinical site. In this stage, the subjects will be divided into 3 application doses.

The following procedures will be performed:

- Time point 0- IV line, BP, Heart Rate, Blood testing (chemistry, blood count, Cannabinoids) and clinician evaluation of cannabis related psychological aspect (such as evaluation the cannabis abuse screening test).

- Time point 6 Hours- BP, Heart Rate Blood testing (chemistry, blood count, Cannabinoids)

- Time point 12- BP, Heart Rate, Blood testing (chemistry, blood count, Cannabinoids)

- Time point 24- BP, Heart Rate, Blood testing (chemistry, blood count, Cannabinoids) and and clinician evaluation of cannabis related psychological aspect (such as evaluation the cannabis abuse screening test).

Part II that will be followed the 24 hours (of part I) is designed to evaluate the repeated applications safety of MGC cream in healthy volunteers for up to 6 weeks, both in the clinic and by subjects at home.

20 healthy subjects that will be treated twice daily with:

- Maximal dose of 30 mg CBD : 30 mg THC, 1:1 ratio

- Placebo Control - 0 mg CBD : 0 mg THC, 1:1 ratio (vehicle)

This stage will be initiated at least 96 hour after completion part I of the study (washout period) .The placebo will be applied on one arm and the control on the second arm. Both, subject and investigator will be blinded as to the product/placebo allocation.

Application at home will be performed twice a day. Subjects will be asked to attend the clinic on day 0 of the part II treatment, once a week during the 6 weeks of daily application and 2 weeks post application. In each visit the following evaluations will be performed: BP, Heart Rate, Blood testing (chemistry, blood count, Cannabinoids) and clinician of cannabis related psychological aspect (such as evaluation the cannabis abuse screening test).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Conditions

Safety Study for Future Treatment of Psoriasis

Intervention

OWC MGC cream, OWC Control Cream

Status

Not yet recruiting

Source

One World Cannabis Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-30T15:45:16-0500

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