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This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | KP405_dose 1, single dose |
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| Cohort 2 | Experimental | KP405_dose 2, single dose |
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| Cohort 3 | Experimental | KP405_dose 3, single dose |
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| Cohort 4 | Experimental | KP405_dose 4, single dose |
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| Cohort 5 | Experimental | KP405_dose 5, single dose |
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| Cohort 6 | Experimental | KP405_dose 6, single dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KP405 | Drug | Experimental drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse event (AE) reporting | Clinical safety data from adverse event (AE) reporting | Through study completion, an average of 1 year |
| 12-lead electrocardiogram (ECG) | Clinical safety data from 12-lead electrocardiogram (ECG) machine will automatically calculate: RR interval PR interval QRS complex QT interval QTcF (QT interval corrected for heart rate using Fridericia's formula) Heart rate (beats per minute) | Through study completion, an average of 1 year |
| Continous ECG monitoring | Clinical safety data from cardiac Holter monitoring | Through study completion, an average of 1 year |
| Blood pressure | Clinical safety data from supine blood pressure (mmHg) | Through study completion, an average of 1 year |
| Pulse rate | Clinical safety data from pulse rate (beats per minute) | Through study completion, an average of 1 year |
| Temperature | Clinical safety data from oral temperature (degrees Celcius) | Through study completion, an average of 1 year |
| Biochemistry parameters in blood samples | Blood chemistry clinical safety data from blood samples. The measurements are: Amylase BUN Creatinine Glucose Sodium Potassium Phosphate Chloride Calcium AST ALT GGT Alkaline phosphatase Total bilirubin Uric acid Albumin Total protein Lactate dehydrogenase |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters - Cmax | Plasma PK concentrations including but not limited to: maximum plasma concentration (Cmax) (ng/ml) | 0-48 hours |
| Pharmacokinetics parameters - tmax | Plasma PK concentrations including but not limited to: time to reach Cmax (tmax) (minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ian Laquian, MBA | Contact | 5170029 | Ian.laquian@kariyapharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Ezanul A Wahab, MD | MAC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MAC | Recruiting | Manchester | United Kingdom |
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| Cohort 7 | Experimental | KP405_dose 1, multiple dose |
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| Cohort 8 | Experimental | KP405_dose 2, multiple dose |
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| Cohort 9 | Experimental | KP405_dose 3, multiple dose |
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| Cohort 10 | Experimental | KP405_dose 4, multiple dose |
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| Cohort 11 | Experimental | KP405_dose 5, multiple dose |
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| Placebo | Drug | Placebo |
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| Through study completion, an average of 1 year |
| Haematology parameters in blood samples | Haematology clinical safety data from blood samples. The measurements are: Haemoglobin Haematocrit RBC count RBC indices (MCV, MCH, MCHC) Platelet count White blood cell count with differential | Through study completion, an average of 1 year |
| Urine samples | Clinical safety data from urinalysis (dipstick*). The following will be measured: Glucose Bilirubin Ketone Specific Gravity Blood pH Protein Urobilinogen Nitrite Leukocyte Esterase *Microscopic analysis if dipstick is abnormal Drugs of abuse: Amphetamines Barbiturates Benzodiazepines Cocaine Cannabinoids Opiates | Through study completion, an average of 1 year |
| Coagulation parameters in blood samples | Coagulation clinical safety data from blood samples. The measurements are: Prothrombin time International normalisation ratio Activated partial thromboplastin time | Through study completion, an average of 1 year |
| Serology parameters in blood samples | Serology clinical safety data from blood samples. The measurements are: Anti-HIV I/II Anti-HCV HBsAg | Through study completion, an average of 1 year |
| Alcohol breath test | Alcohol measurements will be done as a breath test | Through study completion, an average of 1 year |
| Height | As part of a full physical examination the height of the subjects will be measured (in meters) | Through study completion, an average of 1 year |
| Body weight | As part of a full physical examination body weight of the subjects will be measured (in kilograms) | Through study completion, an average of 1 year |
| Assessments of body parts | As part of a full physical examination assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular system, abdomen (liver and spleen), lymph nodes and extremities will be conducted | Through study completion, an average of 1 year |
| Injection site reactions | Clinical safety data from injection site reactions | Through study completion, an average of 1 year |
| 0-48 hours |
| Pharmacokinetics parameters - AUC0-t | Plasma PK concentrations including but not limited to: area under the plasma concentration-time curve (AUC) from zero to the last quantifiable concentration () (ng/ml x hours) | 0-48 hours |
| Pharmacokinetics parameters - AUC0-∞ | Plasma PK concentrations including but not limited to: AUC from zero to infinity (AUC0-∞)(ng/ml x hours) | 0-48 hours |
| Pharmacokinetics parameters - AUC0-24h | Plasma PK concentrations including but not limited to: AUC from zero to 24 hours () (ng/ml x hours) | 0-48 hours |
| Pharmacokinetics parameters - AUC0-48h | Plasma PK concentrations including but not limited to: AUC from zero to 48 hours (AUC0-48h) (ng/ml x hours) | 0-48 hours |
| Pharmacokinetics parameters - half life | Plasma PK concentrations including but not limited to: half life (t1/2) (hours) | 0-48 hours |
| Pharmacodynamic parameters-Pupillometry | The pupillometry measurements will be completed in a room where ambient noise and lighting will be controlled and uniform. After resting for 5 minutes, and before and after receiving the study drug, the pupillometry measurements (repeated once) will be taken from each eye using a pupilometer with an opaque rubber cup covering one eye. Each pupillometry session measuring both eyes will be approximately 1 minute. | Through study completion, an average of 1 year |
| Pharmacodynamic parameters - EEG | Absolute and relative power spectral densities (PSDs) calculated for each 1 second epoch (1-59 Hz bins). Also grouped into the standard EEG bandwidths: delta, theta, alpha, beta and gamma. Additionally, the PSD variables will be averaged across brain regions of interest, including frontal, central, parietal, temporal and occipital | Through study completion, an average of 1 year |
| Pharmacodynamic parameters - Food VAS | The following questions will be asked:
| Through study completion, an average of 1 year |
| Pharmacodynamic parameters- Daily Food Diary | "You are required to keep an up-to-date food diary for the next few days, recording everything you consume (all nutrition that passes your lips)" | Through study completion, an average of 1 year |
| Pharmacodynamic parameters - Test Meal | The test meal model is an accepted experimental method for assessing the effects of an intervention on food intake in a laboratory setting. In its simplest form, it involves offering participants an excess amount of pre-weighed food (a pasta-based meal), instructing participants to eat the test meal until they feel comfortably full, and then weighing the amount of food remaining once the participant has finished eating.13 The weight of food consumed can then be determined (±0.1 g) and from the nutritional information on the food packaging, energy intake (kJ) can be calculated. | Through study completion, an average of 1 year |
| Pharmacodynamic parameters - Appetite and Palatability Questionnaire | This questionnaire consists of thirteen VAS questions and one multiple choice question which in sum examine the palatability of the test meal, the participants' motivation to eat, the general wellbeing and physiological sensations of the participants, and the reason why they stopped eating. The VAS questions are self-rated by the participant by putting a perpendicular marking on each of the thirteen 100 mm lines | Through study completion, an average of 1 year |