CC100: Safety and Tolerability of Single Doses

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02050334

Run by

Chemigen, LLC

People needed

18

Starts

2013-11-01

Expected to finish

2015-02-01

Last updated by the study team

2015-04-30

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• IU Health Neuroscience Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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