Safety IssuesEarly Phase 1NCT06189170

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

A Early Phase 1 study testing KP405 in people with Safety Issues and Tolerance, run by Kariya Pharmaceuticals at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Safety Issues, Tolerance
What is being tested?: KP405
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 88 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Aug 2024to 15 Jun 2026
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

MAC
Manchester

Other trials in United Kingdom

About this study

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.

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

Conditions: Safety Issues, Tolerance
Being tested: KP405, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KP405Drug
Experimental drug
PlaceboDrug
Placebo

Study groups in NCT06189170
Study group	Role	What they receive
Cohort 1	Experimental	KP405_dose 1, single dose Receives: Drug: KP405; Drug: Placebo
Cohort 2	Experimental	KP405_dose 2, single dose Receives: Drug: KP405; Drug: Placebo
Cohort 3	Experimental	KP405_dose 3, single dose Receives: Drug: KP405; Drug: Placebo
Cohort 4	Experimental	KP405_dose 4, single dose Receives: Drug: KP405; Drug: Placebo
Cohort 5	Experimental	KP405_dose 5, single dose Receives: Drug: KP405; Drug: Placebo
Cohort 6	Experimental	KP405_dose 6, single dose Receives: Drug: KP405; Drug: Placebo
Cohort 7	Experimental	KP405_dose 1, multiple dose Receives: Drug: KP405; Drug: Placebo
Cohort 8	Experimental	KP405_dose 2, multiple dose Receives: Drug: KP405; Drug: Placebo
Cohort 9	Experimental	KP405_dose 3, multiple dose Receives: Drug: KP405; Drug: Placebo
Cohort 10	Experimental	KP405_dose 4, multiple dose Receives: Drug: KP405; Drug: Placebo
Cohort 11	Experimental	KP405_dose 5, multiple dose Receives: Drug: KP405; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse event (AE) reporting
Clinical safety data from adverse event (AE) reporting
Measured: 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)
Measured: Through study completion, an average of 1 year
Continous ECG monitoring
Clinical safety data from cardiac Holter monitoring
Measured: Through study completion, an average of 1 year
Blood pressure
Clinical safety data from supine blood pressure (mmHg)
Measured: Through study completion, an average of 1 year
Pulse rate
Clinical safety data from pulse rate (beats per minute)
Measured: Through study completion, an average of 1 year
Temperature
Clinical safety data from oral temperature (degrees Celcius)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 year
Alcohol breath test
Alcohol measurements will be done as a breath test
Measured: 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)
Measured: 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)
Measured: 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
Measured: Through study completion, an average of 1 year
Injection site reactions
Clinical safety data from injection site reactions
Measured: Through study completion, an average of 1 year

Secondary outcomes (13)

Pharmacokinetics parameters - Cmax
Plasma PK concentrations including but not limited to: maximum plasma concentration (Cmax) (ng/ml)
Measured: 0-48 hours
Pharmacokinetics parameters - tmax
Plasma PK concentrations including but not limited to: time to reach Cmax (tmax) (minutes)
Measured: 0-48 hours
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)
Measured: 0-48 hours
Pharmacokinetics parameters - AUC0-∞
Plasma PK concentrations including but not limited to: AUC from zero to infinity (AUC0-∞)(ng/ml x hours)
Measured: 0-48 hours
Pharmacokinetics parameters - AUC0-24h
Plasma PK concentrations including but not limited to: AUC from zero to 24 hours () (ng/ml x hours)
Measured: 0-48 hours
Pharmacokinetics parameters - AUC0-48h
Plasma PK concentrations including but not limited to: AUC from zero to 48 hours (AUC0-48h) (ng/ml x hours)
Measured: 0-48 hours
Pharmacokinetics parameters - half life
Plasma PK concentrations including but not limited to: half life (t1/2) (hours)
Measured: 0-48 hours
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.
Measured: Through study completion, an average of 1 year
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
Measured: Through study completion, an average of 1 year
Pharmacodynamic parameters - Food VAS
The following questions will be asked:
1. How hungry do you feel (from 'not hungry at all' to 'very hungry')?
2. How full do you feel (from 'not full at all' to 'very full')?
3. How satisfied do you feel (from 'completely empty' to 'I cannot eat more')?
4. How much do you think you can eat now (from 'nothing at all' to 'a lot')?
Measured: Through study completion, an average of 1 year
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)"
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
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
Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202415 Jun 2026

First posted3 Jan 2024
Study start1 Aug 2024
Primary completion15 Jun 2026
Study completion15 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Safety IssuesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06189170
Sponsor's protocol ID: KP405CS01
Status last verified: Aug 2026
First submitted: 13 Nov 2023
Last updated: 5 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT06189170
Acronym / sponsor ID: KP405CS01
Conditions: Safety Issues, Tolerance
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Kariya PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 1 Aug 2024 (actual)
Primary completion: 15 Jun 2026 (actual)
Study completion: 15 Jun 2026 (actual)
First posted: 3 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 11

Arm	Type	Receives
Cohort 1	Experimental	Drug: KP405, Drug: PlaceboKP405_dose 1, single dose
Cohort 2	Experimental	Drug: KP405, Drug: PlaceboKP405_dose 2, single dose
Cohort 3	Experimental	Drug: KP405, Drug: PlaceboKP405_dose 3, single dose
Cohort 4	Experimental	Drug: KP405, Drug: PlaceboKP405_dose 4, single dose
Cohort 5	Experimental	Drug: KP405, Drug: PlaceboKP405_dose 5, single dose
Cohort 6	Experimental	Drug: KP405, Drug: PlaceboKP405_dose 6, single dose
Cohort 7	Experimental	Drug: KP405, Drug: PlaceboKP405_dose 1, multiple dose
Cohort 8	Experimental	Drug: KP405, Drug: PlaceboKP405_dose 2, multiple dose
Cohort 9	Experimental	Drug: KP405, Drug: PlaceboKP405_dose 3, multiple dose
Cohort 10	Experimental	Drug: KP405, Drug: PlaceboKP405_dose 4, multiple dose
Cohort 11	Experimental	Drug: KP405, Drug: PlaceboKP405_dose 5, multiple dose

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KP405Experimental drug	Drug	Cohort 1, Cohort 10, Cohort 11, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9
PlaceboPlacebo	Drug	Cohort 1, Cohort 10, Cohort 11, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9

Primary outcome

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

13 secondary outcomes

Pharmacokinetics parameters - Cmax
Time frame: 0-48 hours
Pharmacokinetics parameters - tmax
Time frame: 0-48 hours
Pharmacokinetics parameters - AUC0-t
Time frame: 0-48 hours
Pharmacokinetics parameters - AUC0-∞
Time frame: 0-48 hours
Pharmacokinetics parameters - AUC0-24h
Time frame: 0-48 hours
Pharmacokinetics parameters - AUC0-48h
Time frame: 0-48 hours
Pharmacokinetics parameters - half life
Time frame: 0-48 hours
Pharmacodynamic parameters-Pupillometry
Time frame: Through study completion, an average of 1 year
Pharmacodynamic parameters - EEG
Time frame: Through study completion, an average of 1 year
Pharmacodynamic parameters - Food VAS
Time frame: Through study completion, an average of 1 year
Pharmacodynamic parameters- Daily Food Diary
Time frame: Through study completion, an average of 1 year
Pharmacodynamic parameters - Test Meal
Time frame: Through study completion, an average of 1 year
Pharmacodynamic parameters - Appetite and Palatability Questionnaire
Time frame: Through study completion, an average of 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ezanul A Wahab, MD principal investigator

MAC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing KP405 in people with Safety Issues and Tolerance, run by Kariya Pharmaceuticals at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse event (AE) reporting (time frame: Through study completion, an average of 1 year). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06189170.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.