A Dose-escalating Clinical Trial With KH176

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Khondrion BV
• Collaborator: Drug Research Unit Ghent, Belgium
• Treatments: 6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid

Criteria

Inclusion Criteria:

• Healthy as assessed by medical history, physical examination, Vital Signs, Clinical Laboratory, ECG

Exclusion Criteria:

• Allergies,

• Concomitant medication,

• concomitant disease,

• relevant surgery,

• recent blood donation