Clinical trial NCT06189170: Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Safety Issues
Tolerance
Lead sponsor: Kariya Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-01-03
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will explore the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of KP405 as a potential new treatment for Parkinson's disease.


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse event (AE) reporting
timeFrame: Through study completion, an average of 1 year
measure: 12-lead electrocardiogram (ECG)
timeFrame: Through study completion, an average of 1 year
measure: Continous ECG monitoring
timeFrame: Through study completion, an average of 1 year
measure: Blood pressure
timeFrame: Through study completion, an average of 1 year
measure: Pulse rate
timeFrame: Through study completion, an average of 1 year
measure: Temperature
timeFrame: Through study completion, an average of 1 year
measure: Biochemistry parameters in blood samples
timeFrame: Through study completion, an average of 1 year
measure: Haematology parameters in blood samples
timeFrame: Through study completion, an average of 1 year
measure: Urine samples
timeFrame: Through study completion, an average of 1 year
measure: Coagulation parameters in blood samples
timeFrame: Through study completion, an average of 1 year
measure: Serology parameters in blood samples
timeFrame: Through study completion, an average of 1 year
measure: Alcohol breath test
timeFrame: Through study completion, an average of 1 year
measure: Height
timeFrame: Through study completion, an average of 1 year
measure: Body weight
timeFrame: Through study completion, an average of 1 year
measure: Assessments of body parts
timeFrame: Through study completion, an average of 1 year
measure: Injection site reactions
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Pharmacokinetics parameters - Cmax
timeFrame: 0-48 hours
measure: Pharmacokinetics parameters - tmax
timeFrame: 0-48 hours
measure: Pharmacokinetics parameters - AUC0-t
timeFrame: 0-48 hours
measure: Pharmacokinetics parameters - AUC0-∞
timeFrame: 0-48 hours
measure: Pharmacokinetics parameters - AUC0-24h
timeFrame: 0-48 hours
measure: Pharmacokinetics parameters - AUC0-48h
timeFrame: 0-48 hours
measure: Pharmacokinetics parameters - half life
timeFrame: 0-48 hours
measure: Pharmacodynamic parameters-Pupillometry
timeFrame: Through study completion, an average of 1 year
measure: Pharmacodynamic parameters - EEG
timeFrame: Through study completion, an average of 1 year
measure: Pharmacodynamic parameters - Food VAS
timeFrame: Through study completion, an average of 1 year
measure: Pharmacodynamic parameters- Daily Food Diary
timeFrame: Through study completion, an average of 1 year
measure: Pharmacodynamic parameters - Test Meal
timeFrame: Through study completion, an average of 1 year
measure: Pharmacodynamic parameters - Appetite and Palatability Questionnaire
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: MAC
Study officials:
affiliation: MAC
name: Ezanul A Wahab, MD
role: PRINCIPAL_INVESTIGATOR
References: