drugset / Trial / NCT03888716
A Phase Ia/Ib, SAD and MAD Study of of KL1333 in Healthy Subjects and Patients With Primary Mitochondrial Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This will be a double blind, randomised, placebo controlled, single and multiple oral dose study conducted in 3 parts: Part A, Part B and Part C. Part A and Part B include healthy volunteers only and will be completed before Part C including patients with primary mitochondrial disease will be initiated. The starting dose in the first cohort of Part A will be 25 mg. The dose level in the additional cohorts will be decided following review of data of the previous cohorts.
Timeline
- Start
- 2019-03-18
- Primary completion
- 2021-03-16
- Completion
- 2021-03-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Napazimone | Small molecule | 25 mg | Oral |
| Subject | Napazimone | Small molecule | 100 mg | Oral |