drugset / Trial / NCT03049046

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

NCT03049046 ↗

Phase 1 Unknown 21 enrolled Chemigen, LLC
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2017-04-07
Primary completion
2018-01-30
Completion
2018-03-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator CC100 Unknown 250 mg Oral
Comparator CC100 Unknown 500 mg Oral
Comparator CC100 Unknown 1000 mg Oral