CC100: Safety and Tolerability of Single Doses

Study Overview
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Brief Summary
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The purpose of this study is to see if CC100, given by mouth, is safe and is tolerated in increasing doses. How long the drug remains in the body will also be calculated.

Detailed Description
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Approximately 18 healthy subjects will be randomized to receive by mouth either 3 single increasing doses of CC100 or 1 dose of placebo and 2 increasing doses of CC100. Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. Subjects are required to stay in the Clinic for approximately 24 hours following each dose. Subjects may choose to have an optional lumbar puncture following the 3rd dose of study drug.

Official Title
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Protocol CC100A CC100: Safety and Tolerability of Single Doses

Conditions
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Healthy

Intervention / Treatment
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* Drug: CC100
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men must practice a reliable method of birth control during study and for 2 weeks following study. Women must be non-fertile or post-menopausal. Exclusion Criteria: Have serious or unstable illnesses as determined by the investigator. Have current or a history of asthma, or severe drug allergies or pollen allergy. Have used medications (except for calcium supplements or externally applied eye drops or antibiotics) within 30 days prior to dosing or are expected to use other medications during the study. Have had serious infectious disease affecting the brain within the preceding 5 years; or have known or existing evidence of serious infection. Have laboratory test values that are considered clinically significant as determined by the investigator. Have ECG abnormalities that are clinically significant. Have donated blood (a pint or more) or received an experimental drug within 30 days prior to dosing. Have a history of chronic alcohol or drug abuse within the past 2 years.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CC100 (3 single doses)<br>CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. | Drug: CC100<br>* CC100 reconstituted in diluent<br>* Other names: synthetic caffeic acid phenethylester;|
| Experimental: CC100 (2 single doses) & placebo(1 dose)<br>CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. | Drug: CC100<br>* CC100 reconstituted in diluent<br>* Other names: synthetic caffeic acid phenethylester;Drug: Placebo<br>* Diluent. Amount to match CC100 dose.<br>* Other names: Inactive vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unsolicited Adverse Event Reports | Safety and Tolerability assessed by arm/group and dose received measured by number of unsolicited AEs within a minimum of 24 hours after each dose. | Minimum of 24 hours after each dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100 | 
| Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Healthy Volunteer, Safety, Healthy Volunteer Safety Study