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

A Phase I Study of KW-6356 in Japanese and Caucasian Healthy Adults

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

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: 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

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Medical Co. LTA Sumida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; All study cohorts (except Part C) are placebo controlled.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part A Number and percentage of subjects with treatment-emergent adverse events	Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part B Number and percentage of subjects with treatment-emergent adverse events	Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part C Profiles of pharmacokinetics of plasma KW-6356 concentrations	Starting about 24 hours before dosing and continued until about 7-14 days after last dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Part A Profiles of pharmacokinetics of plasma KW-6356 concentrations	Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part B Profiles of pharmacokinetics of plasma KW-6356 concentrations	Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part C Number and percentage of subjects with treatment-emergent adverse events	Starting about 24 hours before dosing and continued until about 7-14 days after last dose

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2019
• Primary Completion (Actual): October 10, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: February 3, 2019
• First Submitted That Met QC Criteria: February 3, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 6356-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No