CC100: Phase 1 Multiple-Dose Safety and Tolerability in Subjects With ALS

• Status: Unknown status
• Trial end date: 2018-03-30
• Target enrollment: 0
• Participant gender: All

Summary

Approximately 21 subjects with amyotrophic lateral sclerosis (ALS) will be randomized (6 to 1) to receive by mouth seven morning doses of CC100 or placebo for 7 days. Subjects are required to stay in the Clinic for approximately 9 hours following the first and last dose. Subjects will also have a mid-week clinic visit and will be contacted by phone within 3 to 5 days after the last dose.

Funding Source - FDA OOPD

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chemigen, LLC
• Treatments: Caffeic acid

Criteria

Inclusion Criteria:

• Have definite or probable ALS with a forced vital capacity of >60% predicted.

• 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.

• Riluzole is allowed if dose has been stable for at least 30 days. Other allowed medications: lipid-lowering drugs, anti-hypertensives, anti-depressants, oral medications for type II diabetes, estrogen replacement therapy, thyroid replacement therapy, antihistamines, antacids, nonsteroidal anti-inflammatory drugs (except indomethacin), histamine H2-receptor antagonists, proton-pump inhibitors, calcium supplements, topical eye medications, and topical antibiotics.

Exclusion Criteria:

• Greater than 250 pounds

• Have serious or unstable illnesses as determine by the investigator.

• Have current or a history of asthma or severe drug allergies or pollen allergy.

• Have had serious infectious disease affecting the brain within the preceding 5 years; or have existing evidence of serious infection.

• Have laboratory test values that are considered clinically significant as determined by the investigators.

• 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.