Trials / NCT03888716
A Phase Ia/Ib, SAD and MAD Study of of KL1333 in Healthy Subjects and Patients With Primary Mitochondrial Disease
Completed Phase 1 Drug / neuroprotection
- Sponsor
- Abliva AB
- Treatment
- KL1333; Placebo Oral Tablet
- Gene
- Not stated
- Conditions
- Mitochondrial Diseases, Mitochondrial Respiratory Chain Deficiencies, MELAS Syndrome, Mitochondrial Myopathies
- Ages
- 18 Years to 75 Years
- Enrollment
- 72 participants
- Started
- 2019-03-18
- Main results expected
- 2021-03-16
- Results posted
- Not yet
- Record last updated
- 2021-10-20
What the study is testing
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.
Where it runs
United Kingdom (2)
- Covance Leeds, Leeds, West Yorkshire
- UCL, London