Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients

Safety Issues Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06189170
• Other study ID #: KP405CS01
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 10, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: January 2024
• Source: Kariya Pharmaceuticals
• Contact: Ian Laquian, MBA
• Phone: 5170029
• Email: Ian.laquian[@]kariyapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Safety Issues
• Tolerance

Intervention

Drug:
• KP405
Experimental drug
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kariya Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event (AE) reporting	Clinical safety data from adverse event (AE) reporting	Through study completion, an average of 1 year
Primary	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
Primary	Continous ECG monitoring	Clinical safety data from cardiac Holter monitoring	Through study completion, an average of 1 year
Primary	Blood pressure	Clinical safety data from supine blood pressure (mmHg)	Through study completion, an average of 1 year
Primary	Pulse rate	Clinical safety data from pulse rate (beats per minute)	Through study completion, an average of 1 year
Primary	Temperature	Clinical safety data from oral temperature (degrees Celcius)	Through study completion, an average of 1 year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Alcohol breath test	Alcohol measurements will be done as a breath test	Through study completion, an average of 1 year
Primary	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
Primary	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
Primary	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
Primary	Injection site reactions	Clinical safety data from injection site reactions	Through study completion, an average of 1 year
Secondary	Pharmacokinetics parameters - Cmax	Plasma PK concentrations including but not limited to: maximum plasma concentration (Cmax) (ng/ml)	0-48 hours
Secondary	Pharmacokinetics parameters - tmax	Plasma PK concentrations including but not limited to: time to reach Cmax (tmax) (minutes)	0-48 hours
Secondary	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
Secondary	Pharmacokinetics parameters - AUC0-8	Plasma PK concentrations including but not limited to: AUC from zero to infinity (AUC0-8)(ng/ml x hours)	0-48 hours
Secondary	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
Secondary	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
Secondary	Pharmacokinetics parameters - half life	Plasma PK concentrations including but not limited to: half life (t1/2) (hours)	0-48 hours
Secondary	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
Secondary	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
Secondary	Pharmacodynamic parameters - Food VAS	The following questions will be asked: How hungry do you feel (from 'not hungry at all' to 'very hungry')?; How full do you feel (from 'not full at all' to 'very full')?; How satisfied do you feel (from 'completely empty' to 'I cannot eat more')?; How much do you think you can eat now (from 'nothing at all' to 'a lot')?	Through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	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