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
Age range
18 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF)
Timeframe: Baseline, 1, 2, 4, 6, 8, 12, 24 hours, 7 day follow up
Pharmacodynamics of KH176
Timeframe: Day 1, day 7
Relationship to Study Drug and Severity of Treatment-emergent Adverse Events
Timeframe: 4 months
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group)
Timeframe: Baseline (pre-dose Day1), 24h post dose, FU (7 days after last dosing)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days after last dosing)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group
Timeframe: Baseline (pre-dose Day 1), 24 h postdose, FU (7 days after last dosing)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD
Timeframe: Baseline (pre-dose Day 1), 24 h post dose, FU (7 days after last dosing)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD
Timeframe: Baseline (pre-dose Day 1), 24 h post dose, FU (7 days after last dosing)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD
Timeframe: Baseline (pre-dose Day 1), 24 h post dose, FU (7 days after last dosing)
MAD: Change From Baseline in ECG Results by Time Point: QTcF
Timeframe: Baseline, Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h, FU (7 days post-dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post-dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post-dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group
Timeframe: Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroid-stimulating Hormone. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Thyroxine (T4). SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lactate. SAD Group
Timeframe: Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Protein. MAD Group
Timeframe: Baseline (pre-dose Day1), Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alkaline Phosphatase. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Aspartate Aminotransferase. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatine Kinase. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Gamma GT. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Total Bilirubin. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Urea. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Creatinine. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Sodium. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Potassium. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Chloride. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Calcium (Corrected for Albumin). MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Uric Acid. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lipase. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Alanine Aminotransferase. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Phosphate. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Human Serum Albumin. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Fasting Glucose. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Cholesterol. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Triglycerides. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Low Density Lipoproteins. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: High Density Lipoproteins. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroid-stimulating Hormone. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Trilodothyronine (T3). MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Thyroxine (T4). MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Bicarbonate. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Change From Baseline in Chemistry Laboratory Test Results by Time Point: Lactate. MAD Group
Timeframe: Baseline, Day 3, Day 8, FU (one week after last dosing)
Phospholipidosis
Timeframe: Day 1, Day 7
MAD: Change From Baseline in ECG Results by Time Point: Corrected QT Interval According to Barret's Formaula (QTcB)
Timeframe: Baseline (pre-dose Day 1), Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Follow-up
MAD: Change From Baseline in ECG Results by Time Point: P Wave-Q Wave Interval (PQ Interval)
Timeframe: Baseline (pre-dose Day 1), Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Follow-up
MAD: Change From Baseline in ECG Results by Time Point: the Interval That Denotes Depolarization of the Ventricles, Between the Beginning of the Q Wave and the End of the S Wave (QRS Interval)
Timeframe: Baseline (pre-dose Day 1), Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Follow-up
MAD: Change From Baseline in ECG Results by Time Point: QT Interval
Timeframe: Baseline (pre-dose Day 1), Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Follow-up
SAD: Change From Baseline in ECG Results by Time Point: PQ Interval
Timeframe: Pre-dose, Day 1, Day 7
SAD: Change From Baseline in ECG Results by Time Point: QRS Interval
Timeframe: Pre-dose, Day 1, Day 7
SAD: Change From Baseline in ECG Results by Time Point: QT Interval
Timeframe: Pre-dose, Day 1, Day 7
SAD: Change From Baseline in ECG Results by Time Point: QTcB Interval
Timeframe: Pre-dose, Day1, Day 7
Terminal Elimination Half-life (T1/2) of KH176 Over 24 Hours: SAD
Timeframe: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Terminal Elimination Half-life (T1/2) of KH183: SAD
Timeframe: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Maximum Concentration (Cmax) of KH176: SAD Group
Timeframe: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Maximum Concentration (Cmax) of KH183 Over 24 Hours: SAD
Timeframe: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Maximum Concentration (Cmax) of KH183 (Active Metabolite of KH176): MAD Group
Timeframe: Predose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Maximum Concentration (Cmax) of KH176: MAD
Timeframe: pre-dose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Time to Maximum Concentration (Tmax) of KH176 Over 24 Hours: SAD
Timeframe: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Time to Reach Peak Plasma Concentration (Tmax) of KH183: SAD
Timeframe: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Time to Maximum Concentration (Tmax) of KH176 at Day 1, Day 7: MAD Group
Timeframe: pre-dose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Time to Maximum Concentration (Tmax) of KH183 (Active Metabolite of KH176): MAD Group
Timeframe: Predose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Accumulation Factor (Racc) of KH176 Over 7 Days: MAD Group
Timeframe: Pre-dose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Accumulation Factor (Racc) of KH183 (Active Metabolite of KH176): MAD Group
Timeframe: Predose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH183: SAD Group
Timeframe: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUClast) of KH176: SAD Group
Timeframe: pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Area Under the Plasma Concentration-time Curve (AUCtau) of KH176: MAD Group:
Timeframe: Pre-dose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Area Under the Plasma Concentration-time Curve During a Dose Interval (AUCtau) of KH183 (Active Metabolite of KH176): MAD Group
Timeframe: Predose at Day 1, 2, 4, 7, and post-dose at Day 1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH183: SAD
Timeframe: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
Area Under the Plasma Concentration-time Curve From Time Zero Until Infinity (AUCl0-inf) of KH176: SAD
Timeframe: Pre-dose (5 min before dosing) and 0.5, 1, 1.5, 2, 3, 6, 8, 12, and 24 hours post-dose
KH176: Percentage of Administered Dose Excreted in Urine: SAD
Timeframe: 24 hours post-dose
KH183: Percentage of Administered Dose Excreted in Urine: SAD
Timeframe: 24 hours post-dose
KH176 + KH183: Percentage of Administered Dose Excreted in Urine: SAD
Timeframe: 24 hours post-dose
KH176: Percentage of Administered Dose Excreted in Urine: MAD
Timeframe: Day 7 post dose
KH183: Percentage of Administered Dose Excreted in Urine: MAD
Timeframe: Post dose Day 7
KH173 + KH183: Percentage of Administered Dose Excreted in Urine: MAD
Timeframe: Day 7 Post dose