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A Dose-escalating Clinical Trial With KH176

NCT ID: NCT02544217

Last Updated: 2021-10-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-10-31

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single Escalating

2 alternating groups receiving escalating single doses of active/placebo

Group Type EXPERIMENTAL

KH176

Intervention Type DRUG

placebo

Intervention Type DRUG

Multiple Escalating

3 multiple escalating groups, receiving active/placebo

Group Type EXPERIMENTAL

KH176

Intervention Type DRUG

placebo

Intervention Type DRUG

Interventions

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KH176

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Ghent

OTHER

Sponsor Role collaborator

Khondrion BV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Drug Research Unit Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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Koene S, Spaans E, Van Bortel L, Van Lancker G, Delafontaine B, Badilini F, Beyrath J, Smeitink J. KH176 under development for rare mitochondrial disease: a first in man randomized controlled clinical trial in healthy male volunteers. Orphanet J Rare Dis. 2017 Oct 16;12(1):163. doi: 10.1186/s13023-017-0715-0.

Reference Type DERIVED
PMID: 29037240 (View on PubMed)

Other Identifiers

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KH176-101

Identifier Type: -

Identifier Source: org_study_id