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

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ClinicalTrials.gov Identifier: NCT03830528
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

Brief Summary:
Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of KW-6356 in healthy volunteers

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: KW-6356 Low Dose Drug: KW-6356 Middle Dose Drug: KW-6356 High Dose Drug: KW-6356 X Dose Drug: KW-6356 Y Dose Drug: Placebo Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I Study of KW-6356 in Japanese and Caucasian Healthy Adults
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A-1
There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.
Drug: KW-6356 Low Dose
KW-6356 will be administered as single doses.

Experimental: Part A-2
There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.
Drug: KW-6356 Middle Dose
KW-6356 will be administered as single doses.

Experimental: Part A-3
There will be 3 cohorts of Japanese healthy men dosed with single doses of KW-6356 (3 planned dose levels) or with placebo.
Drug: KW-6356 High Dose
KW-6356 will be administered as single doses.

Experimental: Part B
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)
Drug: KW-6356 X Dose
KW-6356 will be administered as multiple doses.

Experimental: Part C-1
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)
Drug: KW-6356 Y Dose
KW-6356 will be administered for Japanese healthy men as multiple doses.

Experimental: Part C-2
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)
Drug: KW-6356 Y Dose
KW-6356 will be administered for Japanese healthy men as multiple doses.

Placebo Comparator: Placebo Drug: Placebo
All study cohorts (except Part C) are placebo controlled.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830528


Contacts
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Contact: Kyowa Hakko Kirin Co., Ltd. please contact us by email clinical.info@kyowa-kirin.co.jp

Locations
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Japan
Medical Co. LTA Sumida Hospital Recruiting
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd

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Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT03830528     History of Changes
Other Study ID Numbers: 6356-004
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases