A Phase I, Randomised, Double-Blinded, Placebo-Controlled Study to Evaluate KP405. Part 1: Single Ascending Dosing in Healthy Participants. Part 2: Multiple Ascending Dosing in Healthy Participants and Parkinson's Disease Patients.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Adverse event (AE) reporting
Study Overview
Brief Summary
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, cardiac Holter monitoring and clinical laboratory evaluations.
- •Clinical diagnosis of Parkinson's disease meeting United Kingdom Brain Bank criteria.
Exclusion Criteria
- •Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder), excluding Parkinson's disease.
- •Clinically significant, as judged by the Investigator, neurologic disorder (other than Parkinson's disease) including history of stroke or transient ischaemic attack within 12 months of Screening, cognitive impairment, seizure within 5 years of Screening or head trauma with loss of consciousness within 6 months of Screening.
Arms & Interventions
Cohort 5
KP405_dose 5, single dose
Intervention: Placebo (Drug)
Cohort 7
KP405_dose 1, multiple dose
Intervention: Placebo (Drug)
Cohort 2
KP405_dose 2, single dose
Intervention: KP405 (Drug)
Cohort 3
KP405_dose 3, single dose
Intervention: KP405 (Drug)
Cohort 4
KP405_dose 4, single dose
Intervention: KP405 (Drug)
Cohort 5
KP405_dose 5, single dose
Intervention: KP405 (Drug)
Cohort 6
KP405_dose 6, single dose
Intervention: KP405 (Drug)
Cohort 7
KP405_dose 1, multiple dose
Intervention: KP405 (Drug)
Cohort 8
KP405_dose 2, multiple dose
Intervention: Placebo (Drug)
Cohort 8
KP405_dose 2, multiple dose
Intervention: KP405 (Drug)
Cohort 9
KP405_dose 3, multiple dose
Intervention: Placebo (Drug)
Cohort 10
KP405_dose 4, multiple dose
Intervention: KP405 (Drug)
Cohort 11
KP405_dose 5, multiple dose
Intervention: Placebo (Drug)
Cohort 11
KP405_dose 5, multiple dose
Intervention: KP405 (Drug)
Cohort 1
KP405_dose 1, single dose
Intervention: Placebo (Drug)
Cohort 2
KP405_dose 2, single dose
Intervention: Placebo (Drug)
Cohort 1
KP405_dose 1, single dose
Intervention: KP405 (Drug)
Cohort 3
KP405_dose 3, single dose
Intervention: Placebo (Drug)
Cohort 4
KP405_dose 4, single dose
Intervention: Placebo (Drug)
Cohort 6
KP405_dose 6, single dose
Intervention: Placebo (Drug)
Cohort 10
KP405_dose 4, multiple dose
Intervention: Placebo (Drug)
Cohort 9
KP405_dose 3, multiple dose
Intervention: KP405 (Drug)
Outcomes
Primary Outcomes
Adverse event (AE) reporting
Time Frame: Through study completion, an average of 1 year
Clinical safety data from adverse event (AE) reporting
12-lead electrocardiogram (ECG)
Time Frame: Through study completion, an average of 1 year
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)
Continous ECG monitoring
Time Frame: Through study completion, an average of 1 year
Clinical safety data from cardiac Holter monitoring
Blood pressure
Time Frame: Through study completion, an average of 1 year
Clinical safety data from supine blood pressure (mmHg)
Pulse rate
Time Frame: Through study completion, an average of 1 year
Clinical safety data from pulse rate (beats per minute)
Temperature
Time Frame: Through study completion, an average of 1 year
Clinical safety data from oral temperature (degrees Celcius)
Biochemistry parameters in blood samples
Time Frame: Through study completion, an average of 1 year
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
Haematology parameters in blood samples
Time Frame: Through study completion, an average of 1 year
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
Urine samples
Time Frame: Through study completion, an average of 1 year
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
Coagulation parameters in blood samples
Time Frame: Through study completion, an average of 1 year
Coagulation clinical safety data from blood samples. The measurements are: Prothrombin time International normalisation ratio Activated partial thromboplastin time
Serology parameters in blood samples
Time Frame: Through study completion, an average of 1 year
Serology clinical safety data from blood samples. The measurements are: Anti-HIV I/II Anti-HCV HBsAg
Alcohol breath test
Time Frame: Through study completion, an average of 1 year
Alcohol measurements will be done as a breath test
Height
Time Frame: Through study completion, an average of 1 year
As part of a full physical examination the height of the subjects will be measured (in meters)
Body weight
Time Frame: Through study completion, an average of 1 year
As part of a full physical examination body weight of the subjects will be measured (in kilograms)
Assessments of body parts
Time Frame: Through study completion, an average of 1 year
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
Injection site reactions
Time Frame: Through study completion, an average of 1 year
Clinical safety data from injection site reactions
Secondary Outcomes
- Pharmacokinetics parameters - Cmax(0-48 hours)
- Pharmacokinetics parameters - tmax(0-48 hours)
- Pharmacokinetics parameters - AUC0-t(0-48 hours)
- Pharmacokinetics parameters - AUC0-∞(0-48 hours)
- Pharmacokinetics parameters - AUC0-24h(0-48 hours)
- Pharmacokinetics parameters - AUC0-48h(0-48 hours)
- Pharmacokinetics parameters - half life(0-48 hours)
- Pharmacodynamic parameters-Pupillometry(Through study completion, an average of 1 year)
- Pharmacodynamic parameters - EEG(Through study completion, an average of 1 year)
- Pharmacodynamic parameters - Food VAS(Through study completion, an average of 1 year)
- Pharmacodynamic parameters- Daily Food Diary(Through study completion, an average of 1 year)
- Pharmacodynamic parameters - Test Meal(Through study completion, an average of 1 year)
- Pharmacodynamic parameters - Appetite and Palatability Questionnaire(Through study completion, an average of 1 year)