Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients
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.
1 other identifier
interventional
88
1 country
1
Brief Summary
This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2023
CompletedFirst Posted
Study publicly available on registry
January 3, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedMarch 7, 2025
March 1, 2025
1.4 years
November 13, 2023
March 4, 2025
Conditions
Outcome Measures
Primary Outcomes (16)
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
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
Secondary Outcomes (13)
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
- +8 more secondary outcomes
Study Arms (11)
Cohort 1
EXPERIMENTALKP405\_dose 1, single dose
Cohort 2
EXPERIMENTALKP405\_dose 2, single dose
Cohort 3
EXPERIMENTALKP405\_dose 3, single dose
Cohort 4
EXPERIMENTALKP405\_dose 4, single dose
Cohort 5
EXPERIMENTALKP405\_dose 5, single dose
Cohort 6
EXPERIMENTALKP405\_dose 6, single dose
Cohort 7
EXPERIMENTALKP405\_dose 1, multiple dose
Cohort 8
EXPERIMENTALKP405\_dose 2, multiple dose
Cohort 9
EXPERIMENTALKP405\_dose 3, multiple dose
Cohort 10
EXPERIMENTALKP405\_dose 4, multiple dose
Cohort 11
EXPERIMENTALKP405\_dose 5, multiple dose
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MAC
Manchester, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Ezanul A Wahab, MD
MAC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2023
First Posted
January 3, 2024
Study Start
August 1, 2024
Primary Completion
December 31, 2025
Study Completion
March 31, 2026
Last Updated
March 7, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share