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

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

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

Study Overview

• Status: Unknown
• Conditions: Huntington Disease
• Intervention / Treatment: Drug: CKD-504; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Min Ji Song; Phone Number: 82-2-3149-7853; Email: songmj@ckdpharm.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: In-Jin Jang
    • Principal Investigator: In-Jin Jang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Heredodegenerative Disorders, Nervous System; Dementia; Cognition Disorders; Chorea; Huntington Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Histone Deacetylase Inhibitors
• Other Study ID Numbers: 175MAD17021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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