search
Back to results

A Study of Single and Multiple Doses of KW-6356 in Healthy Subjects

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
KW-6356 Low Dose
KW-6356 Middle Dose
KW-6356 High Dose
KW-6356 X Dose
KW-6356 Y Dose
Placebo
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

20 Years - 44 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals who provided freely-given written consent for participating in this study

  • Men aged 20 ≥ and < 45 at the time of informed consent;

    • Japanese individuals without mixed marriage for at least last two generations, for participating Part A and Part B
    • Japanese and Caucasian individuals without mixed marriage for at least last two generations, for participating Part C
  • Individuals with BMI ≥ 18.5 and < 30.0
  • Individuals with screening results of; resting pulse rate: 40 to 100 bpm, systolic blood pressure: 91 to 140 mmHg, diastolic blood pressure: 40 to 90 mmHg

Exclusion Criteria:

  • Individuals with any current diseases requiring treatment
  • Individuals with current cerebrovascular, gastrointestinal, cardiovascular, hematologic, renal, or liver diseases
  • Individuals with current symptomatic allergy
  • Individuals with current or past drug allergy
  • Individuals with current or past psychiatric disorders
  • Individuals with a history of any autoimmune diseases or malignant tumor
  • Individuals with alcohol or drug dependence, or those who showed any positive result(s) in drug abuse tests
  • Individuals with a history of congestive heart failure, hypokalemia, hypocalcemia, or QT prolongation syndrome
  • Individuals with positive result in any of viral infection tests (HBs antigen, HBs antibody, HBc antibody, HCV antibody, HIV antigen and antibody, and HTLV-1 antibody) or syphilis tests (RPR and TP antibody) at screening.
  • Individuals with abnormality in standard 12-lead ECG that the investigator or subinvestigator determined as clinically significant at screening, Day -1, and before administration of the study drug on Day 1.
  • Individuals who participated in clinical trial(s) of any medical products and received administration of those within 4 months prior to the study drug administration in the current study
  • Individuals who used drugs (including non-prescription drugs, external preparation, vitamins, health supplements, and herbal medicines) within 2 weeks prior to the study drug administration
  • Individuals who consumed grapefruit, or any food and beverage containing grapefruit or St John's Wort within 1 week prior to the study drug administration
  • Individuals who smoked or used stop-smoking aid products (including chewing or eating nicotine-containing products, or application of nicotine patches) within 4 weeks prior to the study drug administration
  • Individuals who admitted to the hospital or had surgery within 3 months prior to the study drug administration
  • Individuals who had any of the following blood drawing for donation, clinical trial, or any other reasons prior to the study drug administration; ≥ 400 mL blood collection within 3 months; ≥ 200 mL blood collection within 4 weeks; or blood collection for pheresis (such as plasmapheresis or plateletpheresis) donation, clinical trial, or any other reasons within 2 weeks
  • Individuals who did not agree to use appropriate contraceptive measures from the day of admission to 12 weeks after the last administration of study drug. The appropriate contraceptive measures are defined as refraining from sexual activity or combining two contraceptive methods including condom, oral contraceptives, intrauterine contraceptive devices or pessary.
  • Any other individuals who were determined as not suitable for participating in this study by the investigator or subinvestigator

Sites / Locations

  • Medical Co. LTA Sumida Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Part A-1

Part A-2

Part A-3

Part B

Part C-1

Part C-2

Placebo

Arm Description

There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.

There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.

There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.

There will be one cohort of Japanese healthy men dosed with multiple doses of KW-6356 or placebo and one potential additional cohort (KW-6356 dose as determined in Part A or placebo)

There will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies)

There will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies)

Outcomes

Primary Outcome Measures

Part A Number and percentage of subjects with treatment-emergent adverse events
Part B Number and percentage of subjects with treatment-emergent adverse events
Part C Profiles of pharmacokinetics of plasma KW-6356 concentrations

Secondary Outcome Measures

Part A Profiles of pharmacokinetics of plasma KW-6356 concentrations
Part B Profiles of pharmacokinetics of plasma KW-6356 concentrations
Part C Number and percentage of subjects with treatment-emergent adverse events

Full Information

First Posted
February 3, 2019
Last Updated
November 27, 2019
Sponsor
Kyowa Kirin Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03830528
Brief Title
A Study of Single and Multiple Doses of KW-6356 in Healthy Subjects
Official Title
A Phase I Study of KW-6356 in Japanese and Caucasian Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of KW-6356 in healthy volunteers
Detailed Description
The study will have 3 parts: In Part A and Part B, a placebo-controlled double-blind study will be conducted to investigate safety, tolerability and pharmacokinetics of a single dose and 14 days multiple doses of KW-6356 in Japanese healthy men, respectively In Part C, an open-label study will be conducted to investigate safety, tolerability and pharmacokinetics of 7 days multiple doses of KW-6356 in Japanese and Caucasian healthy men

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A-1
Arm Type
Experimental
Arm Description
There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.
Arm Title
Part A-2
Arm Type
Experimental
Arm Description
There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.
Arm Title
Part A-3
Arm Type
Experimental
Arm Description
There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.
Arm Title
Part B
Arm Type
Experimental
Arm Description
There will be one cohort of Japanese healthy men dosed with multiple doses of KW-6356 or placebo and one potential additional cohort (KW-6356 dose as determined in Part A or placebo)
Arm Title
Part C-1
Arm Type
Experimental
Arm Description
There will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies)
Arm Title
Part C-2
Arm Type
Experimental
Arm Description
There will be 2 cohort of Japanese and Caucasian healthy men dosed with multiple doses of KW-6356 (KW-6356 dose as determined in the previous studies)
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KW-6356 Low Dose
Intervention Description
KW-6356 will be administered as single doses.
Intervention Type
Drug
Intervention Name(s)
KW-6356 Middle Dose
Intervention Description
KW-6356 will be administered as single doses.
Intervention Type
Drug
Intervention Name(s)
KW-6356 High Dose
Intervention Description
KW-6356 will be administered as single doses.
Intervention Type
Drug
Intervention Name(s)
KW-6356 X Dose
Intervention Description
KW-6356 will be administered as multiple doses.
Intervention Type
Drug
Intervention Name(s)
KW-6356 Y Dose
Intervention Description
KW-6356 will be administered for Japanese healthy men as multiple doses.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
All study cohorts (except Part C) are placebo controlled.
Primary Outcome Measure Information:
Title
Part A Number and percentage of subjects with treatment-emergent adverse events
Time Frame
Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Title
Part B Number and percentage of subjects with treatment-emergent adverse events
Time Frame
Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Title
Part C Profiles of pharmacokinetics of plasma KW-6356 concentrations
Time Frame
Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Secondary Outcome Measure Information:
Title
Part A Profiles of pharmacokinetics of plasma KW-6356 concentrations
Time Frame
Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Title
Part B Profiles of pharmacokinetics of plasma KW-6356 concentrations
Time Frame
Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Title
Part C Number and percentage of subjects with treatment-emergent adverse events
Time Frame
Starting about 24 hours before dosing and continued until about 7-14 days after last dose

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals who provided freely-given written consent for participating in this study Men aged 20 ≥ and < 45 at the time of informed consent; Japanese individuals without mixed marriage for at least last two generations, for participating Part A and Part B Japanese and Caucasian individuals without mixed marriage for at least last two generations, for participating Part C Individuals with BMI ≥ 18.5 and < 30.0 Individuals with screening results of; resting pulse rate: 40 to 100 bpm, systolic blood pressure: 91 to 140 mmHg, diastolic blood pressure: 40 to 90 mmHg Exclusion Criteria: Individuals with any current diseases requiring treatment Individuals with current cerebrovascular, gastrointestinal, cardiovascular, hematologic, renal, or liver diseases Individuals with current symptomatic allergy Individuals with current or past drug allergy Individuals with current or past psychiatric disorders Individuals with a history of any autoimmune diseases or malignant tumor Individuals with alcohol or drug dependence, or those who showed any positive result(s) in drug abuse tests Individuals with a history of congestive heart failure, hypokalemia, hypocalcemia, or QT prolongation syndrome Individuals with positive result in any of viral infection tests (HBs antigen, HBs antibody, HBc antibody, HCV antibody, HIV antigen and antibody, and HTLV-1 antibody) or syphilis tests (RPR and TP antibody) at screening. Individuals with abnormality in standard 12-lead ECG that the investigator or subinvestigator determined as clinically significant at screening, Day -1, and before administration of the study drug on Day 1. Individuals who participated in clinical trial(s) of any medical products and received administration of those within 4 months prior to the study drug administration in the current study Individuals who used drugs (including non-prescription drugs, external preparation, vitamins, health supplements, and herbal medicines) within 2 weeks prior to the study drug administration Individuals who consumed grapefruit, or any food and beverage containing grapefruit or St John's Wort within 1 week prior to the study drug administration Individuals who smoked or used stop-smoking aid products (including chewing or eating nicotine-containing products, or application of nicotine patches) within 4 weeks prior to the study drug administration Individuals who admitted to the hospital or had surgery within 3 months prior to the study drug administration Individuals who had any of the following blood drawing for donation, clinical trial, or any other reasons prior to the study drug administration; ≥ 400 mL blood collection within 3 months; ≥ 200 mL blood collection within 4 weeks; or blood collection for pheresis (such as plasmapheresis or plateletpheresis) donation, clinical trial, or any other reasons within 2 weeks Individuals who did not agree to use appropriate contraceptive measures from the day of admission to 12 weeks after the last administration of study drug. The appropriate contraceptive measures are defined as refraining from sexual activity or combining two contraceptive methods including condom, oral contraceptives, intrauterine contraceptive devices or pessary. Any other individuals who were determined as not suitable for participating in this study by the investigator or subinvestigator
Facility Information:
Facility Name
Medical Co. LTA Sumida Hospital
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Study of Single and Multiple Doses of KW-6356 in Healthy Subjects

We'll reach out to this number within 24 hrs