drugset / Trial / NCT04973657
A Study to Assess the Pharmacodynamics of VK0214 in Male Subjects With AMN
RandomizedSequentialQuadruple-blindOther
Summary
Subjects will be administered multiple doses of VK0214 in a cohort dose escalation process. A total of up to 36 subjects will be enrolled in the study, into one of three dose cohorts. For each cohort, up to 12 subjects will be randomized to receive VK0214 or placebo in a 3:1 ratio so that there will be a total of up to 9 subjects for each of the active doses and up to 3 subjects dosed with placebo in each cohort.
Timeline
- Start
- 2021-06-22
- Primary completion
- 2024-10-09
- Completion
- 2024-11-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VK0214 | Small molecule | 20 mg | — |
| Subject | VK0214 | Small molecule | 40 mg | — |