Phase 1 N=18 Randomized Single-blind Basic Science

CC100: Safety and Tolerability of Single Doses

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02050334 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcome: Primary: Unsolicited Adverse Event Reports — 3; 4 Unsolicited Adverse Event Reports

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: CC100 (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Chemigen, LLC
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Unsolicited Adverse Event Reports	3; 4	—
SECONDARY Pharmacokinetics (PK)	2.7	—
SECONDARY Half-Life (t1/2)	18.5	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02050334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.