drugset / Trial / NCT03049046
CC100: Phase 1 Multiple-Dose Safety and Tolerability in Subjects With ALS
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CC100 | Unknown | 250 mg | Oral |
| Comparator | CC100 | Unknown | 500 mg | Oral |
| Comparator | CC100 | Unknown | 1000 mg | Oral |