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.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Adverse event (AE) reporting
研究概览
简要总结
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort 5
KP405_dose 5, single dose
干预措施: Placebo (Drug)
Cohort 7
KP405_dose 1, multiple dose
干预措施: Placebo (Drug)
Cohort 2
KP405_dose 2, single dose
干预措施: KP405 (Drug)
Cohort 3
KP405_dose 3, single dose
干预措施: KP405 (Drug)
Cohort 4
KP405_dose 4, single dose
干预措施: KP405 (Drug)
Cohort 5
KP405_dose 5, single dose
干预措施: KP405 (Drug)
Cohort 6
KP405_dose 6, single dose
干预措施: KP405 (Drug)
Cohort 7
KP405_dose 1, multiple dose
干预措施: KP405 (Drug)
Cohort 8
KP405_dose 2, multiple dose
干预措施: Placebo (Drug)
Cohort 8
KP405_dose 2, multiple dose
干预措施: KP405 (Drug)
Cohort 9
KP405_dose 3, multiple dose
干预措施: Placebo (Drug)
Cohort 10
KP405_dose 4, multiple dose
干预措施: KP405 (Drug)
Cohort 11
KP405_dose 5, multiple dose
干预措施: Placebo (Drug)
Cohort 11
KP405_dose 5, multiple dose
干预措施: KP405 (Drug)
Cohort 1
KP405_dose 1, single dose
干预措施: Placebo (Drug)
Cohort 2
KP405_dose 2, single dose
干预措施: Placebo (Drug)
Cohort 1
KP405_dose 1, single dose
干预措施: KP405 (Drug)
Cohort 3
KP405_dose 3, single dose
干预措施: Placebo (Drug)
Cohort 4
KP405_dose 4, single dose
干预措施: Placebo (Drug)
Cohort 6
KP405_dose 6, single dose
干预措施: Placebo (Drug)
Cohort 10
KP405_dose 4, multiple dose
干预措施: Placebo (Drug)
Cohort 9
KP405_dose 3, multiple dose
干预措施: KP405 (Drug)
结局指标
主要结局
Adverse event (AE) reporting
时间窗: Through study completion, an average of 1 year
Clinical safety data from adverse event (AE) reporting
12-lead electrocardiogram (ECG)
时间窗: 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
时间窗: Through study completion, an average of 1 year
Clinical safety data from cardiac Holter monitoring
Blood pressure
时间窗: Through study completion, an average of 1 year
Clinical safety data from supine blood pressure (mmHg)
Pulse rate
时间窗: Through study completion, an average of 1 year
Clinical safety data from pulse rate (beats per minute)
Temperature
时间窗: Through study completion, an average of 1 year
Clinical safety data from oral temperature (degrees Celcius)
Biochemistry parameters in blood samples
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Through study completion, an average of 1 year
Alcohol measurements will be done as a breath test
Height
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Through study completion, an average of 1 year
Clinical safety data from injection site reactions
次要结局
- 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)