Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease

A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02970019

Enrollment

Registered

2016-11-21

Start date

2017-03-30

Completion date

2019-05-28

Last updated

2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief summary

This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease

Interventions

DRUGK0706

Once a day administration after fast

DRUGPlacebo

Once a day administration after fast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Willing and able to give written, and dated, informed consent (or legally acceptable representative/impartial witness when applicable) and is available for the entire study 2. Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's opinion), and be accessible for follow-up 3. Male or female aged 18 to 65 years (both inclusive) 4. Diagnosed with Parkinson's disease

Exclusion criteria

1. Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced parkinsonism 2. Diagnosis of Parkinson's disease Dementia (probable, possible) 3. Presence of severe dyskinesias 4. History of brain surgery for Parkinson's disease

Design outcomes

Primary

Measure	Time frame
Adverse events	4 weeks

Secondary

Measure	Time frame
Time of observed peak plasma concentration	4 weeks
Peak plasma concentration	4 weeks
Area under the plasma concentration versus time curve	4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026