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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Safety Issues Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

KP405\_dose 1, single dose

Group Type EXPERIMENTAL

KP405

Intervention Type DRUG

Experimental drug

Placebo

Intervention Type DRUG

Placebo

Cohort 2

KP405\_dose 2, single dose

Group Type EXPERIMENTAL

KP405

Intervention Type DRUG

Experimental drug

Placebo

Intervention Type DRUG

Placebo

Cohort 3

KP405\_dose 3, single dose

Group Type EXPERIMENTAL

KP405

Intervention Type DRUG

Experimental drug

Placebo

Intervention Type DRUG

Placebo

Cohort 4

KP405\_dose 4, single dose

Group Type EXPERIMENTAL

KP405

Intervention Type DRUG

Experimental drug

Placebo

Intervention Type DRUG

Placebo

Cohort 5

KP405\_dose 5, single dose

Group Type EXPERIMENTAL

KP405

Intervention Type DRUG

Experimental drug

Placebo

Intervention Type DRUG

Placebo

Cohort 6

KP405\_dose 6, single dose

Group Type EXPERIMENTAL

KP405

Intervention Type DRUG

Experimental drug

Placebo

Intervention Type DRUG

Placebo

Cohort 7

KP405\_dose 1, multiple dose

Group Type EXPERIMENTAL

KP405

Intervention Type DRUG

Experimental drug

Placebo

Intervention Type DRUG

Placebo

Cohort 8

KP405\_dose 2, multiple dose

Group Type EXPERIMENTAL

KP405

Intervention Type DRUG

Experimental drug

Placebo

Intervention Type DRUG

Placebo

Cohort 9

KP405\_dose 3, multiple dose

Group Type EXPERIMENTAL

KP405

Intervention Type DRUG

Experimental drug

Placebo

Intervention Type DRUG

Placebo

Cohort 10

KP405\_dose 4, multiple dose

Group Type EXPERIMENTAL

KP405

Intervention Type DRUG

Experimental drug

Placebo

Intervention Type DRUG

Placebo

Cohort 11

KP405\_dose 5, multiple dose

Group Type EXPERIMENTAL

KP405

Intervention Type DRUG

Experimental drug

Placebo

Intervention Type DRUG

Placebo

Interventions

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KP405

Experimental drug

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes