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

Kariya Pharmaceuticals

Status and phase: Enrolling; Early Phase 1

Conditions: Tolerance; Safety Issues

Treatments: Drug: KP405; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06189170

KP405CS01

Details and patient eligibility

About

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

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

88 participants in 11 patient groups

Cohort 1

Experimental group

Description:

KP405_dose 1, single dose

Treatment:

Drug: Placebo

Drug: KP405

Cohort 2

Experimental group

Description:

KP405_dose 2, single dose

Treatment:

Drug: Placebo

Drug: KP405

Cohort 3

Experimental group

Description:

KP405_dose 3, single dose

Treatment:

Drug: Placebo

Drug: KP405

Cohort 4

Experimental group

Description:

KP405_dose 4, single dose

Treatment:

Drug: Placebo

Drug: KP405

Cohort 5

Experimental group

Description:

KP405_dose 5, single dose

Treatment:

Drug: Placebo

Drug: KP405

Cohort 6

Experimental group

Description:

KP405_dose 6, single dose

Treatment:

Drug: Placebo

Drug: KP405

Cohort 7

Experimental group

Description:

KP405_dose 1, multiple dose

Treatment:

Drug: Placebo

Drug: KP405

Cohort 8

Experimental group

Description:

KP405_dose 2, multiple dose

Treatment:

Drug: Placebo

Drug: KP405

Cohort 9

Experimental group

Description:

KP405_dose 3, multiple dose

Treatment:

Drug: Placebo

Drug: KP405

Cohort 10

Experimental group

Description:

KP405_dose 4, multiple dose

Treatment:

Drug: Placebo

Drug: KP405

Cohort 11

Experimental group

Description:

KP405_dose 5, multiple dose

Treatment:

Drug: Placebo

Drug: KP405