drugset / Trial / NCT03888716

A Phase Ia/Ib, SAD and MAD Study of of KL1333 in Healthy Subjects and Patients With Primary Mitochondrial Disease

NCT03888716

Phase 1 Completed 72 enrolled Abliva AB
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

EvaluationDrugModalityDoseRoute
Subject Napazimone Small molecule 25 mg Oral
Subject Napazimone Small molecule 100 mg Oral