Back to resultsCKD-504 in SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects
Primary Purpose
Huntington Disease
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-504
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Huntington Disease
Eligibility Criteria
Inclusion Criteria:
- Healthy adult Korean or Caucasian aged 19 to 45 (inclusive) years, at the time of screening.
- Subjects weighing ≥ 50 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
- Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study.
- Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.
Exclusion Criteria:
- Subjects with a history of hypersensitivities to the drug, including investigational drugs or other drugs or with a history of clinically significant hypersensitivities.
- Subjects with a history of drug abuse or a positive urine screening for drug abuse.
- Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within three months prior to study drug administration.
- Subjects who have donated a unit of whole blood within 60 days or blood components within 30 days prior to study drug administration.
- Subjects judged ineligible for the study after a review of the clinical laboratory results by the investigator or for other reasons.
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CKD-504
Placebo
Arm Description
investigational Drug
investigational Drug
Outcomes
Primary Outcome Measures
Cmax of CKD-504
Peak Plasma Concentration (Cmax) of CKD-504
AUC of CKD-504
Area under the plasma concentration versus time curve (AUC) of CKD-504
Secondary Outcome Measures
Full Information
NCT ID
NCT03713892
First Posted
October 17, 2018
Last Updated
February 21, 2020
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT03713892
Brief Title
CKD-504 in SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects
Official Title
Phase I Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, PK, PD of CKD-504 in Single SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of CKD-504 compared to placebo in healthy Korean and Caucasian adult subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CKD-504
Arm Type
Experimental
Arm Description
investigational Drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
investigational Drug
Intervention Type
Drug
Intervention Name(s)
CKD-504
Other Intervention Name(s)
HDAC inhibitor
Intervention Description
orally administered once with investigational drug assigned on 1d morning with 240 mL of water
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
orally administered
Primary Outcome Measure Information:
Title
Cmax of CKD-504
Description
Peak Plasma Concentration (Cmax) of CKD-504
Time Frame
Day1, Day2, Day3, Day4
Title
AUC of CKD-504
Description
Area under the plasma concentration versus time curve (AUC) of CKD-504
Time Frame
Day1, Day2, Day3, Day4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adult Korean or Caucasian aged 19 to 45 (inclusive) years, at the time of screening.
Subjects weighing ≥ 50 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study.
Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.
Exclusion Criteria:
Subjects with a history of hypersensitivities to the drug, including investigational drugs or other drugs or with a history of clinically significant hypersensitivities.
Subjects with a history of drug abuse or a positive urine screening for drug abuse.
Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within three months prior to study drug administration.
Subjects who have donated a unit of whole blood within 60 days or blood components within 30 days prior to study drug administration.
Subjects judged ineligible for the study after a review of the clinical laboratory results by the investigator or for other reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Ji Song
Phone
82-2-3149-7853
Email
songmj@ckdpharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-Sang Yu
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In-Jin Jang
First Name & Middle Initial & Last Name & Degree
In-Jin Jang
12. IPD Sharing Statement
Plan to Share IPD
No
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CKD-504 in SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects
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