drugset / Trial / NCT02570997
Ascending Dose Study of CT1812 in Healthy Volunteers
RandomizedParallel-groupQuadruple-blindBasic science
Summary
This is a double-blind, placebo controlled, ascending dose, multi-cohort trial. The study will be conducted in two phases: a single ascending dose (SAD) phase "Part A", followed by a multiple ascending dose (MAD) phase "Part B". In Part A, subjects will receive one dose of study drug. In Part B, subjects within a cohort will receive the same dose daily for 14 days. In both parts, sequential cohorts will be exposed to increasing doses of CT1812 in order to identify the maximum tolerated dose (MTD).
Timeline
- Start
- 2015-09
- Primary completion
- 2016-05
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CT1812 | Small molecule | 10 mg | — |
| Comparator | CT1812 | Small molecule | 30 mg | — |
| Comparator | CT1812 | Small molecule | 90 mg | — |
| Comparator | CT1812 | Small molecule | 180 mg | — |
| Comparator | CT1812 | Small molecule | 360 mg | — |
| Comparator | CT1812 | Small molecule | 650 mg | — |