CKD-504 in SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Huntington Disease

Intervention / Treatment
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* Drug: CKD-504
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-504<br>investigational Drug | Drug: CKD-504<br>* orally administered once with investigational drug assigned on 1d morning with 240 mL of water<br>* Other names: HDAC inhibitor;|
| Placebo Comparator: Placebo<br>investigational Drug | Drug: Placebo<br>* orally administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of CKD-504 | Peak Plasma Concentration (Cmax) of CKD-504 | Day1, Day2, Day3, Day4 | 
| AUC of CKD-504 | Area under the plasma concentration versus time curve (AUC) of CKD-504 | Day1, Day2, Day3, Day4 |