CC100: Safety and Tolerability of Single Doses

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CC100; Drug: Placebo

• Registration Number: NCT02050334
• Lead Sponsor: Chemigen, LLC

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-30
• Primary Completion: 2014-07
• Study Completion: 2015-02
• Results First Submitted: 2015-02-18
• Status Verified: 2015-04
• Results First Submitted QC: 2015-04-12
• Last Update Submitted: 2015-04-28
• Results First Posted: 2015-04-29
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CC100 (3 single doses)	CC100	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.
CC100 (2 single doses) & placebo(1 dose)	CC100	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.
CC100 (2 single doses) & placebo(1 dose)	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Unsolicited Adverse Event Reports	Minimum of 24 hours after each dose.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IU Health Neuroscience Center; 🇺🇸 Indianapolis, Indiana, United States