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

Status unconfirmed · Phase 1 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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

Key facts

Study ID

NCT03049046

Run by

Chemigen, LLC

People needed

21

Starts

2017-04-07

Expected to finish

2018-03-30

Last updated by the study team

2017-08-03

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Indiana University, IU Health Physicians Neurology — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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