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

NCT02976779 | Completed Phase 1 DMC

• 1 other identifier: OWC-PSO-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Safety Study for Future Treatment of Psoriasis

Outcome Measures

Primary Outcomes (2)

• Incidence rate of AEs/ SAEs

  Collection of Adverse events and Serious Adverse Events

  24 hours

• Incidence rate of AEs/ SAEs

  Collection of Adverse events and Serious Adverse Events

  6 weeks

Secondary Outcomes (2)

• Specific AEs/ SAEs

  Baseline to 24 hours

• Specific AEs/ SAEs

  baseline to 6 weeks

Study Arms (2)

OWC MGC cream

EXPERIMENTAL

Cannabis based topical cream 3% CBD and 3% THC. The cream was designed to treat Psoriasis . The cream will be applied twice daily.

Drug: OWC MGC cream

OWC Control Cream

PLACEBO COMPARATOR

Carrier cream. CBD and THC were taken out from the formulation. The cream will be applied twice daily.

Drug: OWC Control Cream

Interventions

OWC MGC cream DRUG

Topical cream containing 3% CBD and 3% THC for Psoriasis treatment

Also known as: OWC psoriasis cream

OWC MGC cream

OWC Control Cream DRUG

Topical Cream without active ingredients

OWC Control Cream

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin \<=1.5xupper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECGs).
• A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the OWC Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
• Subjects with hemoglobin (Hb) values higher than ULN the normal range should always be excluded from enrollment.
• A female subject is eligible to participate if she is of non-childbearing potential (postmenopausal or pre-menopausal females with a documented tubal ligation or hysterectomy). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in the protocol.
• Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol.
• Agree not to participate in any other interventional clinical trials during the study
• Agree to follow study instructions meticulously

You may not qualify if:

• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• Have evidence of significant, uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal, or neurological disease. (Participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
• History of malignancy within 5 years of Screening or those with a strong family history of cancer (e.g., familial cancer disorders), with the exception of squamous cell or basal cell carcinoma of the skin that has been definitively treated.
• A history of drug or alcohol abuse, or a history of regular alcohol consumption within 6 months of the study defined as an average weekly intake of \>14 drinks for males or \>7 drinks for females. One drink is equivalent to 12 gram of alcohol: 12 ounces (360 mililiter \[mL\]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
• Consumption of: Barbiturates, Cocaine, Ethanol, SSRI's, Protease inhibitors, Warfarin, Sildenafil, Theophilline, Tricyclic antidepressants
• A positive test for human immunodeficiency virus (HIV) antibody.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives (whichever is longer).
• Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and OWC Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or OWC Medical Monitor, contraindicates their participation.
• Pregnant females as determined by positive urine human chorionic gonadotropin test at screening or prior to dosing.
• Are pregnant or nursing, or of child bearing potential and not practicing an effective means of birth control.
• Are not able to give adequate informed consent.
• Have any current problem or a history of substance abuse which, in the opinion of the investigator, might interfere with participation in the protocol.
• Have used marijuana within a month of starting the study.

Sponsors & Collaborators

• One World Cannabis Ltd.: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: November 29, 2016
• Study Start: February 3, 2017
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)