NCT02544217

A Dose-escalating Clinical Trial With KH176

A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Clinical Trial With KH176

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Khondrion BV · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Mitochondrial Diseases are rare progressive, multi-system, often early fatal disorders affecting both children and adults. KH176 is a novel chemical entity currently under development for the treatment of inherited mitochondrial diseases, including MELAS (Mitochondrial Encephalomyopathy, Lactic acidosis, and Stroke-like episodes), Leigh's Disease and Leber's Hereditary Optic Neuropathy (LHON). KH176 is a potent intracellular redox modulating agent targeting the reactive oxygen species which are important in the pathogenesis of disorders of mitochondrial oxidative phosphorylation. After demonstrating a favourable safety profile in the pre-clinical testing, the safety, tolerability and pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in healthy male subjects in this trial

Conditions

• MELAS
• LHON
• Leigh Syndrome
• Mitochondrial Disease
• Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation

Interventions

Type	Name	Description
DRUG	KH176
DRUG	placebo

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2015-09-09
• Last updated: 2021-10-18
• Results posted: 2020-11-12

Locations

1 site across 1 country: Belgium